Nitrogen Balance in Infants After Post Cardiothoracic Surgery

NCT01368705 | Completed Phase 4 DMC

• 1 other identifier: 1000012920
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congenital Heart Disease

Keywords

Infants; Nitrogen Balance; Cardiothoracic surgery; Congenital heart disease; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Dietary Supplement: Standard protein delivery

Intervention Group 1

EXPERIMENTAL

Dietary Supplement: Intervention 1 (2.2g/kg/day)

Intervention Group 2

EXPERIMENTAL

Dietary Supplement: Intervention 2 (3.0 g/kg/day)

Interventions

Standard protein delivery DIETARY_SUPPLEMENT

Protein delivery of 1.5 g/kg/day.

Control Group

Intervention 1 (2.2g/kg/day) DIETARY_SUPPLEMENT

protein delivery of 2.2g/kg/day

Intervention Group 1

Intervention 2 (3.0 g/kg/day) DIETARY_SUPPLEMENT

protein delivery of 3.0 g/kg/day

Intervention Group 2

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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hours following admission to the CCCU; as indicated by the need for frequent blood transfusion these subjects will be withdrawn from the study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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V 1B2, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Malnutrition

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Paul B Pencharz, MD

  The Hospital for Sick Children, Toronto, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Scientist

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: August 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

CA (1)