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Nitrogen Balance in Infants After Post Cardiothoracic Surgery

NCT ID: NCT01368705

Last Updated: 2013-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Congenital Heart Disease

Keywords

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Infants Nitrogen Balance Cardiothoracic surgery Congenital heart disease Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type ACTIVE_COMPARATOR

Standard protein delivery

Intervention Type DIETARY_SUPPLEMENT

Protein delivery of 1.5 g/kg/day.

Intervention Group 1

Group Type EXPERIMENTAL

Intervention 1 (2.2g/kg/day)

Intervention Type DIETARY_SUPPLEMENT

protein delivery of 2.2g/kg/day

Intervention Group 2

Group Type EXPERIMENTAL

Intervention 2 (3.0 g/kg/day)

Intervention Type DIETARY_SUPPLEMENT

protein delivery of 3.0 g/kg/day

Interventions

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Standard protein delivery

Protein delivery of 1.5 g/kg/day.

Intervention Type DIETARY_SUPPLEMENT

Intervention 1 (2.2g/kg/day)

protein delivery of 2.2g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Intervention 2 (3.0 g/kg/day)

protein delivery of 3.0 g/kg/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Dr. Paul Pencharz

Emeritus Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul B Pencharz, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto, Canada

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000012920

Identifier Type: -

Identifier Source: org_study_id