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Nitrogen Balance in Infants After Post Cardiothoracic Surgery

This study has been completed.
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children Identifier:
First received: June 6, 2011
Last updated: August 16, 2013
Last verified: August 2013
The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

Condition Intervention Phase
Congenital Heart Disease
Dietary Supplement: Standard protein delivery
Dietary Supplement: Intervention 1 (2.2g/kg/day)
Dietary Supplement: Intervention 2 (3.0 g/kg/day)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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.

Enrollment: 24
Study Start Date: August 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group Dietary Supplement: Standard protein delivery
Protein delivery of 1.5 g/kg/day.
Experimental: Intervention Group 1 Dietary Supplement: Intervention 1 (2.2g/kg/day)
protein delivery of 2.2g/kg/day
Experimental: Intervention Group 2 Dietary Supplement: Intervention 2 (3.0 g/kg/day)
protein delivery of 3.0 g/kg/day

Detailed 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.


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01368705

Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V 1B2
Sponsors and Collaborators
The Hospital for Sick Children
Principal Investigator: Paul B Pencharz, MD The Hospital for Sick Children, Toronto, Canada
  More Information

Responsible Party: Dr. Paul Pencharz, Emeritus Scientist, The Hospital for Sick Children Identifier: NCT01368705     History of Changes
Other Study ID Numbers: 1000012920
Study First Received: June 6, 2011
Last Updated: August 16, 2013

Keywords provided by The Hospital for Sick Children:
Nitrogen Balance
Cardiothoracic surgery
Congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities processed this record on March 30, 2017