Clinical trial NCT01215240: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypoplastic Left Heart Syndrome
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Women and Children's Health Research Institute, Canada
First posted: 2010-10-06
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Time to First Post-operative Negative 24 Hour Fluid Balance
timeFrame: up to 72 hours
Secondary outcomes:
measure: Time to Sternal Closure
timeFrame: Up to 200 hours
measure: Time to Lactate Less Than or Equal to 2mmol/L
timeFrame: From time of admission in PICU until assessment was reached, assessed up to 24 hours
measure: Time to First Extubation
timeFrame: Up to 15 days
measure: Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
timeFrame: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
measure: Hospital Length of Stay
timeFrame: Assessed up to 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Lindsay M Ryerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.