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

Hypoplastic Left Heart Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215240
• Other study ID #: 2010-LR-001
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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)

Related Conditions & MeSH terms

• Hypoplastic Left Heart Syndrome

Intervention

Device:
• Peritoneal dialysis
Prophylactic peritoneal dialysis

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Women and Children's Health Research Institute, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Sternal Closure		Up to 200 hours
Secondary	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
Secondary	Time to First Extubation		Up to 15 days
Secondary	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
Secondary	Hospital Length of Stay		Assessed up to 8 weeks