Nitrogen Balance in Infants After Post Cardiothoracic Surgery

The Hospital for Sick Children

Status and phase

Completed

Phase 4

Conditions

Congenital Heart Disease

Treatments

Dietary Supplement: Standard protein delivery

Dietary Supplement: Intervention 2 (3.0 g/kg/day)

Dietary Supplement: Intervention 1 (2.2g/kg/day)

Study type

Interventional

Funder types

Other

Identifiers

NCT01368705

1000012920

Details and patient eligibility

About

The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

Full description

Postoperative neonates are susceptible to the adverse effects of surgery that is characterized by a breakdown of body stores. Without appropriate nutritional consideration this process can lead to increased physiological instability. It has been extensively documented that critically ill patients are typically catabolic. This results in body nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as, gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants due to their limited fat and lean body mass reserves. Quantifying the amount of protein needed to maintain body composition and to meet the demands of surgical stress is of clinical importance when considering factors associated with postoperative morbidity, such as delayed wound healing, impaired growth and prolonged hospital stay.

The results obtained from this study will assist with determining an appropriate level of protein for the development of optimal nutrition prescriptions that are aimed at reducing catabolism of body stores.

Enrollment

24 patients

Sex

All

Ages

1 day to 12 months old

Volunteers

No Healthy Volunteers

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