Trial Outcomes & Findings for Kidney Response to Sepsis Affects Angiogenic Balance and Likelihood of CCI and PICS (NCT NCT02276066)
NCT ID: NCT02276066
Last Updated: 2024-07-09
Results Overview
The difference between a measured GFR with Iohexol and calculated GFR from creatinine.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis.
Results posted on
2024-07-09
Participant Flow
73 subjects enrolled and 41 completed.
Participant milestones
| Measure |
Inhospital Group at Day 14
This group of sepsis participants remain hospitalized at day 14.
|
Discharged Prior to Hospital Day 14
This group of sepsis participants were discharged prior to day 14.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
32
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
21
|
11
|
Reasons for withdrawal
| Measure |
Inhospital Group at Day 14
This group of sepsis participants remain hospitalized at day 14.
|
Discharged Prior to Hospital Day 14
This group of sepsis participants were discharged prior to day 14.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
11
|
Baseline Characteristics
The iohexol could not be performed in many individuals because it was contraindicated or the injection would interfere with patient care.
Baseline characteristics by cohort
| Measure |
In Hospital Group at Day 14
n=41 Participants
This group of sepsis participants remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push.
|
Discharged From Hospital Prior to Day 14
n=32 Participants
This group of sepsis participants were discharged prior to day 14 and iohexol determination of GFR was done at time of discharge. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=73 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=41 Participants
|
24 Participants
n=32 Participants
|
55 Participants
n=73 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=41 Participants
|
8 Participants
n=32 Participants
|
18 Participants
n=73 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=41 Participants
|
19 Participants
n=32 Participants
|
40 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=41 Participants
|
13 Participants
n=32 Participants
|
33 Participants
n=73 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
8 Participants
n=32 Participants
|
9 Participants
n=73 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=41 Participants
|
24 Participants
n=32 Participants
|
63 Participants
n=73 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=73 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=73 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=41 Participants
|
32 Participants
n=32 Participants
|
73 Participants
n=73 Participants
|
|
GFR by iohexol
|
91.5 ml/min/1.7m2
STANDARD_DEVIATION 46.0 • n=20 Participants • The iohexol could not be performed in many individuals because it was contraindicated or the injection would interfere with patient care.
|
88.3 ml/min/1.7m2
STANDARD_DEVIATION 39.0 • n=11 Participants • The iohexol could not be performed in many individuals because it was contraindicated or the injection would interfere with patient care.
|
90.3 ml/min/1.7m2
STANDARD_DEVIATION 43.0 • n=31 Participants • The iohexol could not be performed in many individuals because it was contraindicated or the injection would interfere with patient care.
|
PRIMARY outcome
Timeframe: For Arm 1 baseline is measured GFR at 14 days inhospital with sepsis or sepsis diagnosis. For Arm 2 baseline is measured GFR at discharge date prior to day 14 of hospitalizaton with sepsis or sepsis diagnosis.Population: GFR by iohexol and eGFR by CKD epi at baseline. The iohexol could not be performed on many patients because it was contraindicated
The difference between a measured GFR with Iohexol and calculated GFR from creatinine.
Outcome measures
| Measure |
Inhospital Group at Day 14
n=41 Participants
This group of sepsis participants will remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine results.
|
Discharged Prior to Day 14 GFR
n=32 Participants
This group of sepsis participants will remain hospitalized after day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. The iohexol will be quantified in urine and blood and glomerular filtration rate quantified. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results.
|
|---|---|---|
|
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline
Iohexol GFR
|
91.5 ml/min/1.73m2
Standard Deviation 46.0
|
88.3 ml/min/1.73m2
Standard Deviation 39.0
|
|
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at Baseline
eGFR by epi formula
|
93.6 ml/min/1.73m2
Standard Deviation 26.6
|
90.0 ml/min/1.73m2
Standard Deviation 28.7
|
PRIMARY outcome
Timeframe: one year follow up for both armsPopulation: The iohexol could not be performed in many individuals because they could not come in to the clinic, would not come into the clinic, or the iohexol injection was contraindicated.
The difference between a measured GFR with Iohexol and calculated GFR from creatinine This was a one-time determination at 1 year follow-up
Outcome measures
| Measure |
Inhospital Group at Day 14
n=3 Participants
This group of sepsis participants will remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine results.
|
Discharged Prior to Day 14 GFR
n=6 Participants
This group of sepsis participants will remain hospitalized after day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. The iohexol will be quantified in urine and blood and glomerular filtration rate quantified. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results.
|
|---|---|---|
|
Delta Curve Between Calculated GFR and GFR Measured by Iohexol at 1 Year Follow-up.
|
71.4 mL/min/1.73m2
Standard Deviation 38.6
|
58.8 mL/min/1.73m2
Standard Deviation 40.9
|
SECONDARY outcome
Timeframe: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalizationThe correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
Outcome measures
| Measure |
Inhospital Group at Day 14
n=41 Participants
This group of sepsis participants will remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine results.
|
Discharged Prior to Day 14 GFR
n=32 Participants
This group of sepsis participants will remain hospitalized after day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. The iohexol will be quantified in urine and blood and glomerular filtration rate quantified. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results.
|
|---|---|---|
|
Estimated GFR by Serum Creatinine
|
96.14 mL/min/1.73m2
Standard Deviation 24.77
|
90.0 mL/min/1.73m2
Standard Deviation 28.7
|
SECONDARY outcome
Timeframe: at 1 year follow-upThe correlation between iohexol glomerular filtration rate and estimated glomerular filtration rate using previously validated equation applied to serum creatinine in both groups.
Outcome measures
| Measure |
Inhospital Group at Day 14
n=20 Participants
This group of sepsis participants will remain hospitalized at day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine results.
|
Discharged Prior to Day 14 GFR
n=21 Participants
This group of sepsis participants will remain hospitalized after day 14. A normal saline dilution of Iohexol 0.5-1 ml will be given IV push. The iohexol will be quantified in urine and blood and glomerular filtration rate quantified. This test will be repeated in one year. In addition to or as an option would be to have a timed urine collection to determine clearance of urea and creatinine can be performed instead of the saline dilution of Iohexol 0.5-1 ml and/or an estimated of GFR using serum creatinine and cystatin C measurement using calculations from blood samples.
Iohexol: Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected and measured to determine glomerular filtration rate measurements. This test will be repeated in one year.
Urine Collection: Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
Blood samples: Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results.
|
|---|---|---|
|
Estimated GFR by Serum Creatinine
|
83.0 ml/min/1.73m2
Standard Deviation 25.3
|
83.2 ml/min/1.73m2
Standard Deviation 29.2
|
SECONDARY outcome
Timeframe: at 14 days inpatient hospitalization or at discharge date prior to day 14 inpatient hospitalizationPopulation: this outcome measure was not performed due to lack of funding prior to initiation of study
The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at one year follow-upPopulation: this outcome measure not performed due to funding cuts prior to initiation of study
The urine will be collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration
Outcome measures
Outcome data not reported
Adverse Events
Inhospital Group at Day 14
Serious events: 24 serious events
Other events: 0 other events
Deaths: 6 deaths
Discharged From Hospital Prior to Day 14
Serious events: 15 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Inhospital Group at Day 14
n=41 participants at risk
This group of sepsis participants will remain hospitalized at day 14. GFR assessment at inpatient day 14 and again at 1 year follow up
|
Discharged From Hospital Prior to Day 14
n=32 participants at risk
The group discharged before 14 days hospitalizaton. GFR assessment at discharge and again at 1 year follow-up
|
|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.2%
5/41 • Number of events 5 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
9.4%
3/32 • Number of events 3 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Gastrointestinal disorders
colostomy reversal
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
0.00%
0/32 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Blood and lymphatic system disorders
Blood Transfusion
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 2 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Skin and subcutaneous tissue disorders
Readmission for wound care
|
14.6%
6/41 • Number of events 6 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Cardiac disorders
Readmission for pacemaker implant
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Vascular disorders
Readmission for planned angiogram
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Gastrointestinal disorders
Esophagael surgery
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Cardiac disorders
Chest pain
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
0.00%
0/32 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
General disorders
Sepsis
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
0.00%
0/32 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
General disorders
Altered Mental Status
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
0.00%
0/32 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
General disorders
Death
|
14.6%
6/41 • Number of events 6 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Renal and urinary disorders
Kidney Stones
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
6.2%
2/32 • Number of events 2 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Hepatobiliary disorders
cholecystectomy
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Gastrointestinal disorders
Pancreatic Surgery
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/41 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
3.1%
1/32 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
|
Infections and infestations
C. Diff infection
|
2.4%
1/41 • Number of events 1 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
0.00%
0/32 • Adverse events were collected for an entire year after consent was signed. We report all adverse events for all individuals enrolled in this trial. No adverse events were related to this trial or the larger trial, but the study involved critically ill subjects, so there were a lot of serious adverse events. Thus all adverse events that occurred after the subject signed consent and for the next 365 days are reported.
We report all adverse events for all individuals enrolled in this trial.
|
Other adverse events
Adverse event data not reported
Additional Information
Mark S. Segal
University of Florida Board of Trustees Contracts & Grants
Phone: 352-273-5357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place