Trial Outcomes & Findings for Daxor - Blood Volume Analysis (NCT NCT04111185)
NCT ID: NCT04111185
Last Updated: 2023-06-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline, and upon discharge (up to day 18)
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Receive Blood Volume Analysis Guided Treatment
The health care team will be provided with BVA (blood volume analysis) results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
|
Overall Study
COMPLETED
|
17
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daxor - Blood Volume Analysis
Baseline characteristics by cohort
| Measure |
Receive Blood Volume Analysis Guided Treatment
n=17 Participants
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
n=14 Participants
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 32 • n=39 Participants
|
60 years
STANDARD_DEVIATION 30 • n=41 Participants
|
61 years
STANDARD_DEVIATION 31 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
23 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, and upon discharge (up to day 18)Outcome measures
| Measure |
Receive Blood Volume Analysis Guided Treatment
n=17 Participants
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
n=14 Participants
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
|---|---|---|
|
Change in Whole Blood Volume
|
-1253 mL
Standard Deviation 2157
|
-784 mL
Standard Deviation 981
|
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18)Population: Data not collected.
Comparison of baseline to follow up times
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to dischargeOutcome measures
| Measure |
Receive Blood Volume Analysis Guided Treatment
n=17 Participants
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
n=14 Participants
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
|---|---|---|
|
Change in Mean NTpro-BNP Concentration (in pg/mL)
|
-853 pg/mL
Standard Deviation 3154
|
-4849 pg/mL
Standard Deviation 6770
|
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to dischargeOutcome measures
| Measure |
Receive Blood Volume Analysis Guided Treatment
n=17 Participants
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
n=14 Participants
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
|---|---|---|
|
Change in Weight (in kg)
|
-6.4 kg
Standard Deviation 5.4
|
-10.1 kg
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18); reported as change from baseline to dischargeOutcome measures
| Measure |
Receive Blood Volume Analysis Guided Treatment
n=17 Participants
The health care team will be provided with BVA results and may use the information to make decisions regarding the participant's treatment.
Receive Blood Volume Analysis Guided Treatment: The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
|
Receive Standard of Care Treatment
n=14 Participants
The health care team will not be provided with the BVA results. The participant will receive the same treatment they would have received if they weren't in the study.
|
|---|---|---|
|
Change in Renal Function as Measured by Creatinine (mg/dL)
|
0.1 mg/dL
Standard Deviation 0.3
|
0.2 mg/dL
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18)Population: Data not collected.
Comparison of baseline to follow up times
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18)Population: Data not collected.
Comparison of baseline to follow up times
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 1, day 2, day 3 and discharge (up to day 18)Population: Data not collected.
Comparison of baseline to follow up times
Outcome measures
Outcome data not reported
Adverse Events
Receive Blood Volume Analysis Guided Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Receive Standard of Care Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place