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N/A N=22 Randomized Treatment

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

Hypoplastic Left Heart Syndrome

Enrolled (actual)
22
Serious AEs
18.2%
Results posted
Aug 2019
Primary outcome: Primary: Time to First Post-operative Negative 24 Hour Fluid Balance — 2.7; 2.67 Days

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Peritoneal dialysis (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of Alberta
Primary completion
Oct 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Time to First Post-operative Negative 24 Hour Fluid Balance
2.7; 2.67
SECONDARY
Time to Sternal Closure
5.33; 4.17
SECONDARY
Time to Lactate Less Than or Equal to 2mmol/L
15.5; 20.3
SECONDARY
Time to First Extubation
10.1; 8.6
SECONDARY
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
16.4; 15.0
SECONDARY
Hospital Length of Stay
20.4; 27.7

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.

Eligibility 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01215240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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