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

NCT01215240 | Completed Results DMC

• 1 other identifier: 2010-LR-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoplastic Left Heart Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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

• Hospital Length of Stay

  Assessed up to 8 weeks

Study Arms (2)

Prophylactic peritoneal dialysis

EXPERIMENTAL

Prophylactic peritoneal dialysis

Device: Peritoneal dialysis

Standard care without PDC

NO INTERVENTION

Interventions

Peritoneal dialysis DEVICE

Prophylactic peritoneal dialysis

Prophylactic peritoneal dialysis

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Women and Children's Health Research Institute, Canada: collaborator

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (1)

• 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.

  PMID: 25218539 DERIVED

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Interventions

Peritoneal Dialysis

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Renal Dialysis; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Results Point of Contact

• Title: Dr. Lindsay Ryerson
• Organization: University of Alberta

ryerson@ualberta.ca

780 407 3396

Study Officials

• Lindsay M Ryerson, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 6, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 2, 2019
• Results First Posted: August 2, 2019

Record last verified: 2019-08

Locations

CA (1)