Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
NCT Number: NCT01215240
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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All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2B7, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prophylactic peritoneal dialysis
Time frame: up to 72 hours
Time to first post-operative negative fluid balance which occurred in first 72 hrs
Time frame: Up to 200 hours
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
Time frame: Up to 15 days
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.
Time frame: Assessed up to 8 weeks
University of Alberta
Other
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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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