Trial Outcomes & Findings for Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass (NCT NCT01709227)
NCT ID: NCT01709227
Last Updated: 2017-06-09
Results Overview
Difference of inputs and outputs, including urine output and PD drainage.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
Postop day 1
Results posted on
2017-06-09
Participant Flow
Participant milestones
| Measure |
Furosemide
Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output \<1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output \>1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.
Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output \<1 ml/kg/hr over 16 hours after the first dose of Lasix
|
Peritoneal Dialysis
Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service
Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.
One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
41
|
|
Overall Study
COMPLETED
|
31
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
9
|
Reasons for withdrawal
| Measure |
Furosemide
Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output \<1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output \>1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.
Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output \<1 ml/kg/hr over 16 hours after the first dose of Lasix
|
Peritoneal Dialysis
Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service
Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.
One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Pleural Peritoneal communication
|
0
|
9
|
Baseline Characteristics
Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass
Baseline characteristics by cohort
| Measure |
Furosemide
n=32 Participants
Patients randomized to receive furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to receive peritoneal dialysis
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9 days
n=99 Participants
|
8 days
n=107 Participants
|
8 days
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
41 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
Weight (kg)
|
3.4 kg
n=99 Participants
|
3.4 kg
n=107 Participants
|
3.4 kg
n=206 Participants
|
|
Length (cm)
|
50 cm
n=99 Participants
|
50 cm
n=107 Participants
|
50 cm
n=206 Participants
|
|
Baseline Creatinine (mg/dL)
|
0.4 mg/dl
n=99 Participants
|
0.4 mg/dl
n=107 Participants
|
0.4 mg/dl
n=206 Participants
|
PRIMARY outcome
Timeframe: Postop day 1Difference of inputs and outputs, including urine output and PD drainage.
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Number of Participants With Negative Fluid Balance on Postop Day 1
|
21 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Duration of postoperative intubation (average time approximately- 1 week)Duration of initial course of postoperative mechanical ventilation
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Respiratory Support Administered
|
4 days
Interval 2.0 to 6.0
|
3 days
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)Population: Data were collected but not analyzed. Due to a high incidence of volatile and un-reportable NGAL levels, concerns were raised about the storage or processing of samples affecting data validity. Given the overwhelming concern of erroneous data, analysis was not performed as planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Average 2 weeksTotal days of initial postoperative stay in cardiac ICU
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Duration of Cardiac ICU Stay
|
9 days
Interval 5.0 to 15.0
|
7 days
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: Average 4 weeksTotal days of initial postoperative stay in hospital
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Duration of Hospital Stay
|
15 days
Interval 10.0 to 28.0
|
14 days
Interval 9.0 to 22.0
|
SECONDARY outcome
Timeframe: duration of hospitalization (an average of 2 weeks)In-hospital mortality
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
All Cause Mortality
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Postop morning 1-5Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Renal/Electrolyte Abnormalities
|
6 abnormalities
Interval 4.0 to 7.0
|
4 abnormalities
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Postop day 0-5Total doses of potassium chloride or arginine chloride given during the first five postoperative days.
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Doses of Potassium Chloride or Arginine Chloride Required
|
2 doses given
Interval 1.0 to 5.0
|
1 doses given
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: At 24hours and 48 hours postoperativeBNP measured at 24 and 48 hours postoperatively
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
B-Natriuretic Peptide
24 hours
|
1334 pg/ml
Interval 901.0 to 2764.0
|
1168 pg/ml
Interval 555.0 to 2439.0
|
|
B-Natriuretic Peptide
48 hours
|
1110 pg/ml
Interval 611.0 to 2221.0
|
663 pg/ml
Interval 486.0 to 1593.0
|
SECONDARY outcome
Timeframe: at 24 and 48 hours postoperativeProduct of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen
Outcome measures
| Measure |
Furosemide
n=32 Participants
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 Participants
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Modified Oxygenation Index
24 Hours
|
4 Units
Interval 3.2 to 5.2
|
4 Units
Interval 0.03 to 5.4
|
|
Modified Oxygenation Index
48 Hours
|
3.8 Units
Interval 2.4 to 5.4
|
2.8 Units
Interval 2.2 to 4.6
|
Adverse Events
Furosemide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Peritoneal Dialysis
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Furosemide
n=32 participants at risk
Patients randomized to furosemide
|
Peritoneal Dialysis
n=41 participants at risk
Patients randomized to peritoneal dialysis
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding Event
|
0.00%
0/32
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hydrocele
|
0.00%
0/32
|
2.4%
1/41 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place