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OpenTrials
Completed

NCT Number: NCT01368705

Nitrogen Balance in Infants After Post Cardiothoracic Surgery

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

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5V 1B2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard protein delivery

Dietary Supplement

Protein delivery of 1.5 g/kg/day.

Intervention 1 (2.2g/kg/day)

Dietary Supplement

protein delivery of 2.2g/kg/day

Intervention 2 (3.0 g/kg/day)

Dietary Supplement

protein delivery of 3.0 g/kg/day

Primary outcomes

  1. Nitrogen Balance

    Time frame: From 0-84 hours

    After an initial adaptation period of approximately 12 hours receiving parenteral nutrition the first 24-hour urine collection for nitrogen balance will be started; following this two successive 24-hour urine collections will be performed in order to obtain a three-day collection for nitrogen balance analyses.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2011
Registry last updated
Aug 19, 2013

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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