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

Not Applicable

Completed

• Conditions: Hypoplastic Left Heart Syndrome
• Interventions: Device: Peritoneal dialysis

• Registration Number: NCT01215240
• Lead Sponsor: University of Alberta

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-05
• Study First Posted: 2010-10-06
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Results First Submitted: 2018-01-25
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-01
• Last Update Submitted: 2019-08-01
• Results First Posted: 2019-08-02
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Infants with HLHS or its variants who have a Norwood procedure
• Parental consent

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic peritoneal dialysis	Peritoneal dialysis	Prophylactic peritoneal dialysis

Primary Outcome Measures

Name	Time	Method
Time to First Post-operative Negative 24 Hour Fluid Balance	up to 72 hours	Time to first post-operative negative fluid balance which occurred in first 72 hrs

Secondary Outcome Measures

Name	Time	Method
Time to Sternal Closure	Up to 200 hours
Time to Lactate Less Than or Equal to 2mmol/L	From time of admission in PICU until assessment was reached, assessed up to 24 hours	Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs
Time to First Extubation	Up to 15 days
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5	Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported	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	Assessed up to 8 weeks

Trial Locations

Locations (1)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada