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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University of Alberta

Current Primary Outcome: Time to first post-operative negative 24 hour fluid balance

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to sternal closure
  • Time to lactate less than or equal to 2mmol/L
  • Time to first extubation
  • Maximum vasoactive inotrope score on post-operative days 2-5
  • Hospital length of stay


Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: October 4, 2010
Date Started: September 2010
Date Completion:
Last Updated: June 22, 2015
Last Verified: June 2015