Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Primary Purpose
Hypoplastic Left Heart Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Peritoneal dialysis
Sponsored by
About this trial
This is an interventional treatment trial for Hypoplastic Left Heart Syndrome
Eligibility Criteria
Inclusion Criteria:
- Infants with HLHS or its variants who have a Norwood procedure
- Parental consent
Exclusion Criteria:
- Premature neonates less than 37 weeks gestation
- Weight less than 2 kg
- Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
- Pre-operative renal replacement therapy
- Abdominal defects precluding placement of a PD catheter
- Known chromosomal abnormality
- Pre-operative cardiopulmonary resuscitation (CPR)
- Pre-operative extra-corporeal life support (ECLS)
Sites / Locations
- Stollery Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prophylactic peritoneal dialysis
Standard care without PDC
Arm Description
Prophylactic peritoneal dialysis
Outcomes
Primary Outcome Measures
Time to First Post-operative Negative 24 Hour Fluid Balance
Time to first post-operative negative fluid balance which occurred in first 72 hrs
Secondary Outcome Measures
Time to Sternal Closure
Time to Lactate Less Than or Equal to 2mmol/L
Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs
Time to First Extubation
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.
Hospital Length of Stay
Full Information
NCT ID
NCT01215240
First Posted
October 4, 2010
Last Updated
August 1, 2019
Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
1. Study Identification
Unique Protocol Identification Number
NCT01215240
Brief Title
Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Official Title
Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.
Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoplastic Left Heart Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic peritoneal dialysis
Arm Type
Experimental
Arm Description
Prophylactic peritoneal dialysis
Arm Title
Standard care without PDC
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Peritoneal dialysis
Intervention Description
Prophylactic peritoneal dialysis
Primary Outcome Measure Information:
Title
Time to First Post-operative Negative 24 Hour Fluid Balance
Description
Time to first post-operative negative fluid balance which occurred in first 72 hrs
Time Frame
up to 72 hours
Secondary Outcome Measure Information:
Title
Time to Sternal Closure
Time Frame
Up to 200 hours
Title
Time to Lactate Less Than or Equal to 2mmol/L
Description
Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs
Time Frame
From time of admission in PICU until assessment was reached, assessed up to 24 hours
Title
Time to First Extubation
Time Frame
Up to 15 days
Title
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
Description
The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.
Time Frame
Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
Title
Hospital Length of Stay
Time Frame
Assessed up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with HLHS or its variants who have a Norwood procedure
Parental consent
Exclusion Criteria:
Premature neonates less than 37 weeks gestation
Weight less than 2 kg
Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
Pre-operative renal replacement therapy
Abdominal defects precluding placement of a PD catheter
Known chromosomal abnormality
Pre-operative cardiopulmonary resuscitation (CPR)
Pre-operative extra-corporeal life support (ECLS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay M Ryerson, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
25218539
Citation
Ryerson LM, Mackie AS, Atallah J, Joffe AR, Rebeyka IM, Ross DB, Adatia I. Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):222-8. doi: 10.1016/j.jtcvs.2014.08.011. Epub 2014 Aug 13.
Results Reference
derived
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Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
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