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

August 1, 2019 updated by: Lindsay Ryerson, University of Alberta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prophylactic peritoneal dialysis
Device: Peritoneal dialysis
Prophylactic peritoneal dialysis
No Intervention: Standard care without PDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Post-operative Negative 24 Hour Fluid Balance
Time Frame: up to 72 hours
Time to first post-operative negative fluid balance which occurred in first 72 hrs
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Sternal Closure
Time Frame: Up to 200 hours
Up to 200 hours
Time to Lactate Less Than or Equal to 2mmol/L
Time Frame: From time of admission in PICU until assessment was reached, assessed up to 24 hours
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
Time to First Extubation
Time Frame: Up to 15 days
Up to 15 days
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
Time Frame: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
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
Hospital Length of Stay
Time Frame: Assessed up to 8 weeks
Assessed up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Women and Children's Health Research Institute, Canada

Investigators

  • Principal Investigator: Lindsay M Ryerson, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 5, 2010

First Posted (Estimate)

October 6, 2010

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-LR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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