MedTrace Logo

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

NCT01215240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-08-02

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

Peritoneal dialysis

Prophylactic peritoneal dialysis

Sponsors & Collaborators

  • Women and Children's Health Research Institute, Canada

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Lindsay M Ryerson, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215240 on ClinicalTrials.gov