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

NCT ID: NCT01215240

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prophylactic peritoneal dialysis

Prophylactic peritoneal dialysis

Group Type: EXPERIMENTAL

Peritoneal dialysis

Intervention Type: DEVICE

Prophylactic peritoneal dialysis

Standard care without PDC

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peritoneal dialysis

Prophylactic peritoneal dialysis

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women and Children's Health Research Institute, Canada

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Ryerson

Clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay M Ryerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Stollery Children's Hospital

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25218539 (View on PubMed)

Other Identifiers

2010-LR-001

Identifier Type: -

Identifier Source: org_study_id