Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

Study Overview
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Brief Summary
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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.

Official Title
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Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

Conditions
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Hypoplastic Left Heart Syndrome

Intervention / Treatment
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* Device: Peritoneal dialysis


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic peritoneal dialysis<br>Prophylactic peritoneal dialysis | Device: Peritoneal dialysis<br>* Prophylactic peritoneal dialysis<br>|
| No Intervention: Standard care without PDC<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Post-operative Negative 24 Hour Fluid Balance | Time to first post-operative negative fluid balance which occurred in first 72 hrs | up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Sternal Closure |  | Up to 200 hours | 
| 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 | From time of admission in PICU until assessment was reached, assessed up to 24 hours | 
| Time to First Extubation |  | Up to 15 days | 
| 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. | Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported | 
| Hospital Length of Stay |  | Assessed up to 8 weeks |