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Nitrogen Balance in Infants After Post Cardiothoracic Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01368705
First received: June 6, 2011
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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

Primary Outcome Measures:
  • Nitrogen Balance [ Time Frame: From 0-84 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 27
Study Start Date: August 2009
Estimated Study Completion Date: June 2012
Estimated 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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368705

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

No publications provided

Responsible Party: Paul Pencharz/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01368705     History of Changes
Other Study ID Numbers: 1000012920
Study First Received: June 6, 2011
Last Updated: June 7, 2011
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013