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Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01709227
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Kidney Injury
Interventions Drug: Furosemide
Procedure: Peritoneal Dialysis
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 32 41
Completed 31 32
Not Completed 1 9
Reason Not Completed
Physician Decision             1             0
Pleural Peritoneal communication             0             9
Arm/Group Title Furosemide Peritoneal Dialysis Total
Hide Arm/Group Description Patients randomized to receive furosemide Patients randomized to receive peritoneal dialysis Total of all reporting groups
Overall Number of Baseline Participants 32 41 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 32 participants 41 participants 73 participants
9
(7 to 14)
8
(6 to 15)
8
(6 to 14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 41 participants 73 participants
Female
11
  34.4%
15
  36.6%
26
  35.6%
Male
21
  65.6%
26
  63.4%
47
  64.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 41 participants 73 participants
Hispanic or Latino
1
   3.1%
1
   2.4%
2
   2.7%
Not Hispanic or Latino
31
  96.9%
40
  97.6%
71
  97.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 41 participants 73 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.1%
0
   0.0%
1
   1.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   6.3%
2
   4.9%
4
   5.5%
White
29
  90.6%
37
  90.2%
66
  90.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   4.9%
2
   2.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 41 participants 73 participants
32 41 73
Weight (kg)  
Median (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 32 participants 41 participants 73 participants
3.4
(3 to 3.8)
3.4
(3 to 3.8)
3.4
(3 to 3.8)
Length (cm)  
Median (Inter-Quartile Range)
Unit of measure:  Cm
Number Analyzed 32 participants 41 participants 73 participants
50
(47 to 53)
50
(47 to 52)
50
(47 to 52)
Baseline Creatinine (mg/dL)  
Median (Inter-Quartile Range)
Unit of measure:  Mg/dl
Number Analyzed 32 participants 41 participants 73 participants
0.4
(0.36 to 0.5)
0.4
(0.34 to 0.53)
0.4
(0.34 to 0.5)
1.Primary Outcome
Title Number of Participants With Negative Fluid Balance on Postop Day 1
Hide Description Difference of inputs and outputs, including urine output and PD drainage.
Time Frame Postop day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Measure Type: Count of Participants
Unit of Measure: Participants
21
  65.6%
29
  70.7%
2.Secondary Outcome
Title Respiratory Support Administered
Hide Description Duration of initial course of postoperative mechanical ventilation
Time Frame Duration of postoperative intubation (average time approximately- 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: days
4
(2 to 6)
3
(2 to 4)
3.Secondary Outcome
Title NGAL Concentration
Hide Description [Not Specified]
Time Frame Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to PD
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Duration of Cardiac ICU Stay
Hide Description Total days of initial postoperative stay in cardiac ICU
Time Frame Average 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: days
9
(5 to 15)
7
(6 to 12)
5.Secondary Outcome
Title Duration of Hospital Stay
Hide Description Total days of initial postoperative stay in hospital
Time Frame Average 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: days
15
(10 to 28)
14
(9 to 22)
6.Secondary Outcome
Title All Cause Mortality
Hide Description In-hospital mortality
Time Frame duration of hospitalization (an average of 2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.4%
1
   2.4%
7.Secondary Outcome
Title Renal/Electrolyte Abnormalities
Hide Description Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol
Time Frame Postop morning 1-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: abnormalities
6
(4 to 7)
4
(3 to 5)
8.Secondary Outcome
Title Doses of Potassium Chloride or Arginine Chloride Required
Hide Description Total doses of potassium chloride or arginine chloride given during the first five postoperative days.
Time Frame Postop day 0-5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: doses given
2
(1 to 5)
1
(0 to 3)
9.Secondary Outcome
Title B-Natriuretic Peptide
Hide Description BNP measured at 24 and 48 hours postoperatively
Time Frame At 24hours and 48 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to peritoneal dialysis
Overall Number of Participants Analyzed 32 41
Mean (Inter-Quartile Range)
Unit of Measure: pg/ml
24 hours
1334
(901 to 2764)
1168
(555 to 2439)
48 hours
1110
(611 to 2221)
663
(486 to 1593)
10.Secondary Outcome
Title Modified Oxygenation Index
Hide Description Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen
Time Frame at 24 and 48 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description:
Patients randomized to furosemide
Patients randomized to PD
Overall Number of Participants Analyzed 32 41
Median (Inter-Quartile Range)
Unit of Measure: Units
24 Hours
4
(3.2 to 5.2)
4
(0.03 to 5.4)
48 Hours
3.8
(2.4 to 5.4)
2.8
(2.2 to 4.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Furosemide Peritoneal Dialysis
Hide Arm/Group Description Patients randomized to furosemide Patients randomized to peritoneal dialysis
All-Cause Mortality
Furosemide Peritoneal Dialysis
Affected / at Risk (%) Affected / at Risk (%)
Total   3/32 (9.38%)      1/41 (2.44%)    
Show Serious Adverse Events Hide Serious Adverse Events
Furosemide Peritoneal Dialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/41 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Furosemide Peritoneal Dialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      2/41 (4.88%)    
Blood and lymphatic system disorders     
Bleeding Event  [1]  0/32 (0.00%)  0 1/41 (2.44%)  1
Skin and subcutaneous tissue disorders     
Hydrocele * [2]  0/32 (0.00%)  0 1/41 (2.44%)  1
Indicates events were collected by systematic assessment
[1]
Bleeding from PD catheter or relating to its placement requiring blood product transfusion.
*
Indicates events were collected by non-systematic assessment
[2]
Development of hydrocele
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Kwiatkowski
Organization: Stanford University
Phone: 650-721-3290
EMail: david.kwiatkowski@stanford.edu
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01709227     History of Changes
Other Study ID Numbers: 2011-1730
First Submitted: September 20, 2012
First Posted: October 18, 2012
Results First Submitted: January 31, 2017
Results First Posted: June 9, 2017
Last Update Posted: June 9, 2017