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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215240
Recruitment Status : Completed
First Posted : October 6, 2010
Results First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborator:
Women and Children's Health Research Institute, Canada
Information provided by (Responsible Party):
Lindsay Ryerson, University of Alberta

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.


Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome Device: Peritoneal dialysis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: Prophylactic peritoneal dialysis
Prophylactic peritoneal dialysis
Device: Peritoneal dialysis
Prophylactic peritoneal dialysis

No Intervention: Standard care without PDC



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to Sternal Closure [ Time Frame: Up to 200 hours ]
  2. 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

  3. Time to First Extubation [ Time Frame: Up to 15 days ]
  4. 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.

  5. Hospital Length of Stay [ Time Frame: Assessed up to 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215240


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lindsay Ryerson, Clinical assistant professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01215240    
Other Study ID Numbers: 2010-LR-001
First Posted: October 6, 2010    Key Record Dates
Results First Posted: August 2, 2019
Last Update Posted: August 2, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities