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=5 Participants	8 days n=7 Participants	8 days n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	40 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	41 participants n=7 Participants	73 participants n=5 Participants
Weight (kg)	3.4 kg n=5 Participants	3.4 kg n=7 Participants	3.4 kg n=5 Participants
Length (cm)	50 cm n=5 Participants	50 cm n=7 Participants	50 cm n=5 Participants
Baseline Creatinine (mg/dL)	0.4 mg/dl n=5 Participants	0.4 mg/dl n=7 Participants	0.4 mg/dl n=5 Participants

PRIMARY outcome

Timeframe: Postop day 1

Difference 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 weeks

Total 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 weeks

Total 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 1-5

Total 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 0-5

Total 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 postoperative

BNP 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 postoperative

Product 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

David Kwiatkowski

Stanford University

Phone: 650-721-3290

Email: david.kwiatkowski@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place