Clinical Trials Directory

Trials / Completed

CompletedNCT01215240

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University of Alberta · Academic / Other
Sex
All
Age
1 Day – 30 Days
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICEPeritoneal dialysisProphylactic peritoneal dialysis

Timeline

Start date
2010-09-01
Primary completion
2013-10-01
Completion
2013-12-01
First posted
2010-10-06
Last updated
2019-08-02
Results posted
2019-08-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01215240. Inclusion in this directory is not an endorsement.