Nitrogen Balance in Infants After Post Cardiothoracic Surgery (NCT01368705) | Clinical Trial Compass
CompletedPhase 4
Nitrogen Balance in Infants After Post Cardiothoracic Surgery
Canada24 participantsStarted 2009-08
Plain-language summary
The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.
Who can participate
Age range1 Day – 12 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical decision to initiate parenteral nutrition based on determination by medical team
* Gestational age ≥ 35 weeks
* Birth weight ≥ 2000 grams
* Indwelling urinary catheters for urine collection
* Central venous access for parenteral nutrition
Exclusion Criteria:
* Chromosomal abnormalities known to effect protein metabolism
* Hepatic failure defined as ALT and AST \> 500 UL with an INR \> 2.5, not accounted for by therapeutic anticoagulation
* Renal failure defined as creatinine 2x the upper limit of normal for age.
* Sepsis or suspected sepsis, defined as clinical suspicion or confirmation of a systemic infection treated with antibiotics
* Excessive blood loss from chest tubes (5 ml/kg/hr) that has not resolved within six hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study
* Requiring Extra Corporeal Membrane Oxygenation (ECMO) support