Nitrogen Balance in Infants After Post Cardiothoracic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368705
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : August 19, 2013
Information provided by (Responsible Party):
Dr. Paul Pencharz, The Hospital for Sick Children

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

Condition or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
Study Start Date : August 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  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.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Dr. Paul Pencharz, Emeritus Scientist, The Hospital for Sick Children Identifier: NCT01368705     History of Changes
Other Study ID Numbers: 1000012920
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

Keywords provided by Dr. Paul Pencharz, 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