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

U

University of Alberta

Status

Completed

Conditions

Hypoplastic Left Heart Syndrome

Treatments

Device: Peritoneal dialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT01215240
2010-LR-001

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

1 to 30 days old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 2 patient groups

Prophylactic peritoneal dialysis
Experimental group
Description:
Prophylactic peritoneal dialysis
Treatment:
Device: Peritoneal dialysis
Standard care without PDC
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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