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Peritoneal Dialysis vs Furosemide for Acute Kidney Injury After Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01709227
First received: September 20, 2012
Last updated: May 4, 2017
Last verified: May 2017
Results First Received: January 31, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Furosemide   Peritoneal Dialysis
STARTED   32   41 
COMPLETED   31   32 
NOT COMPLETED   1   9 
Physician Decision                1                0 
Pleural Peritoneal communication                0                9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Furosemide Patients randomized to receive furosemide
Peritoneal Dialysis Patients randomized to receive peritoneal dialysis
Total Total of all reporting groups

Baseline Measures
   Furosemide   Peritoneal Dialysis   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   41   73 
Age 
[Units: Days]
Median (Inter-Quartile Range)
 9 
 (7 to 14) 
 8 
 (6 to 15) 
 8 
 (6 to 14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  34.4%      15  36.6%      26  35.6% 
Male      21  65.6%      26  63.4%      47  64.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   32   41   73 
Weight (kg) 
[Units: Kg]
Median (Inter-Quartile Range)
 3.4 
 (3 to 3.8) 
 3.4 
 (3 to 3.8) 
 3.4 
 (3 to 3.8) 
Length (cm) 
[Units: Cm]
Median (Inter-Quartile Range)
 50 
 (47 to 53) 
 50 
 (47 to 52) 
 50 
 (47 to 52) 
Baseline Creatinine (mg/dL) 
[Units: Mg/dl]
Median (Inter-Quartile Range)
 0.4 
 (0.36 to 0.5) 
 0.4 
 (0.34 to 0.53) 
 0.4 
 (0.34 to 0.5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Negative Fluid Balance on Postop Day 1   [ Time Frame: Postop day 1 ]

2.  Secondary:   Respiratory Support Administered   [ Time Frame: Duration of postoperative intubation (average time approximately- 1 week) ]

3.  Secondary:   NGAL Concentration   [ Time Frame: Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr) ]

4.  Secondary:   Duration of Cardiac ICU Stay   [ Time Frame: Average 2 weeks ]

5.  Secondary:   Duration of Hospital Stay   [ Time Frame: Average 4 weeks ]

6.  Secondary:   All Cause Mortality   [ Time Frame: duration of hospitalization (an average of 2 weeks) ]

7.  Secondary:   Renal/Electrolyte Abnormalities   [ Time Frame: Postop morning 1-5 ]

8.  Secondary:   Doses of Potassium Chloride or Arginine Chloride Required   [ Time Frame: Postop day 0-5 ]

9.  Secondary:   B-Natriuretic Peptide   [ Time Frame: At 24hours and 48 hours postoperative ]

10.  Secondary:   Modified Oxygenation Index   [ Time Frame: at 24 and 48 hours postoperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: David Kwiatkowski
Organization: Stanford University
phone: 650-721-3290
e-mail: david.kwiatkowski@stanford.edu



Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01709227     History of Changes
Other Study ID Numbers: 2011-1730
Study First Received: September 20, 2012
Results First Received: January 31, 2017
Last Updated: May 4, 2017