Trial record 18 of 31 for:    "Hypoplastic left heart syndrome"

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

This study has been completed.
Sponsor:
Collaborator:
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
Lindsay Ryerson, University of Alberta
ClinicalTrials.gov Identifier:
NCT01215240
First received: October 4, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypoplastic Left Heart Syndrome
Device: Peritoneal dialysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Time to first post-operative negative 24 hour fluid balance [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Enrollment: 22
Study Start Date: September 2010
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylactic peritoneal dialysis
Prophylactic peritoneal dialysis
Device: Peritoneal dialysis
Prophylactic peritoneal dialysis

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215240

Locations
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
Women and Children's Health Research Institute, Canada
Investigators
Principal Investigator: Lindsay M Ryerson, MD University of Alberta
  More Information

No publications provided

Responsible Party: Lindsay Ryerson, Clinical assistant professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01215240     History of Changes
Other Study ID Numbers: 2010-LR-001
Study First Received: October 4, 2010
Last Updated: October 24, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 14, 2014