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Completed

NCT Number: NCT01215240

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

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.

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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Peritoneal dialysis

Device

Prophylactic peritoneal dialysis

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Women and Children's Health Research Institute, Canada

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 6, 2010
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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