Nitrogen Balance in Infants After Post Cardiothoracic Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Dietary supplement: Standard protein delivery; Dietary supplement: Intervention 1 (2.2g/kg/day); Dietary supplement: Intervention 2 (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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5V 1B2
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nitrogen Balance	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.	From 0-84 hours

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Paul B Pencharz, MD, The Hospital for Sick Children, Toronto, Canada

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 6, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Infants; Malnutrition; Congenital heart disease; Nitrogen Balance; Cardiothoracic surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1000012920