← Back to Search

Other

Prophylactic peritoneal dialysis for Hypoplastic Left Heart Syndrome

N/A
Waitlist Available
Led By Lindsay M Ryerson, MD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to First Post-operative Negative 24 Hour Fluid Balance
Secondary outcome measures
Hospital Length of Stay
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
Time to First Extubation
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prophylactic peritoneal dialysisExperimental Treatment1 Intervention
Prophylactic peritoneal dialysis
Group II: Standard care without PDCActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peritoneal dialysis
2008
N/A
~11650

Find a Location

Who is running the clinical trial?

Women and Children's Health Research Institute, CanadaOTHER
17 Previous Clinical Trials
24,918 Total Patients Enrolled
University of AlbertaLead Sponsor
894 Previous Clinical Trials
386,969 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
4 Patients Enrolled for Hypoplastic Left Heart Syndrome
Lindsay M Ryerson, MDPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby May 2025