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Nitrogen Balance in Infants After Post Cardiothoracic Surgery

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Standard protein delivery
Intervention 1 (2.2g/kg/day)
Intervention 2 (3.0 g/kg/day)
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease focused on measuring Infants, Nitrogen Balance, Cardiothoracic surgery, Congenital heart disease, Malnutrition

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

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hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Intervention Group 1

Intervention Group 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2011
Last Updated
August 16, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01368705
Brief Title
Nitrogen Balance in Infants After Post Cardiothoracic Surgery
Official Title
Determination of Protein Needs Using Nitrogen Balance in Infants Immediately Post Cardiothoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Infants, Nitrogen Balance, Cardiothoracic surgery, Congenital heart disease, Malnutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Title
Intervention Group 2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard protein delivery
Intervention Description
Protein delivery of 1.5 g/kg/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 1 (2.2g/kg/day)
Intervention Description
protein delivery of 2.2g/kg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Intervention 2 (3.0 g/kg/day)
Intervention Description
protein delivery of 3.0 g/kg/day
Primary Outcome Measure Information:
Title
Nitrogen Balance
Description
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.
Time Frame
From 0-84 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul B Pencharz, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5V 1B2
Country
Canada

12. IPD Sharing Statement

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Nitrogen Balance in Infants After Post Cardiothoracic Surgery

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