Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition

NCT00181753 | Withdrawn DMC

• 2 other identifiers: 2P50GM021700-27A12004-P-001946
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to understand how the body uses amino acids in burned patients during the time they cannot eat normally. Amino acids occur naturally in the body and the food we eat. The body combines amino acids to make protein. It uses the proteins to do things such as heal wounds, fight infection, and provide energy. We are studying two ways of receiving nutrition: through a vein or through a tube. We are also studying two different types of food: with or without glutamine. The results of this study will be used to determine the best type and way to supply nutrients during a severe burn injury. We hope to learn how to help the body use nutrients more efficiently to better repair wounded tissues and recover earlier from injury.

Conditions

Burns

Keywords

glutamine metabolic kinetics; glutamate metabolic kinetics; enteral nutrition; parenteral nutrition; burn injury; stable isotopes

Outcome Measures

Primary Outcomes (1)

• This is a nutritional study. The primary outcome is to measure the protein kinetics for metabolism of the amino acid, glutamate and glutamine. Fate will be determine from measurements of subject blood and air samples.

  3 days and above

Study Arms (4)

1

EXPERIMENTAL

Burn Patients receiving at least 3 days of parenteral feeding on routine formula

Drug: standard vs. glutamine enteral or parenteral feeding.; Dietary Supplement: Stable isotope tracer study; Dietary Supplement: Stable isotope study

2

EXPERIMENTAL

Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.

Drug: standard vs. glutamine enteral or parenteral feeding.; Dietary Supplement: Stable isotope tracer study; Dietary Supplement: Stable isotope study

3

EXPERIMENTAL

Burn patients receiving at least 3 days of enteral feeding on routine formula.

Drug: standard vs. glutamine enteral or parenteral feeding.; Dietary Supplement: Stable isotope tracer study; Dietary Supplement: Stable isotope study

4

EXPERIMENTAL

Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.

Drug: standard vs. glutamine enteral or parenteral feeding.; Dietary Supplement: Stable isotope tracer study; Dietary Supplement: Stable isotope study

Interventions

standard vs. glutamine enteral or parenteral feeding. DRUG

Patient in each group will continue on the same diet for \> 3 days before we conduct stable isotope tracer measurements.

Also known as: Nutritional Support, Glutamine, Glutamate, Amino Acide

1; 2; 3; 4

Stable isotope tracer study DIETARY_SUPPLEMENT

7 hours of primed constant infusion

Also known as: Glutamine, Stable isotope study

1; 2; 3; 4

Stable isotope study DIETARY_SUPPLEMENT

7 hours of primed constant infusion of stable isotope tracers.

Also known as: Stable isotopes, Glutamine

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more of the following:
• % Total Body Surface Area Thermal Burn
• Inhalation Injury
• Resting Energy Expenditure of \>15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
• Receiving Enteral or Parental Nutritional Support

You may not qualify if:

• Pre-existing:
• Thyroid disease
• Congestive Heart Failure (Ejection fraction \<20%)
• Malignancy currently under treatment
• Medical conditions requiring glucocorticoid treatment
• Decision not to treat because of severity of injury
• Presence of Anoxic brain injury with no expectation for recovery
• Self-Inflicted thermal injury
• Ileus, gut paralysis, or facial injuries
• No NG or OG tube as part of their clinical care

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Massachusetts General Hospital Burn Unit

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Sheridan RL, Prelack K, Yu YM, Lydon M, Petras L, Young VR, Tompkins RG. Short-term enteral glutamine does not enhance protein accretion in burned children: a stable isotope study. Surgery. 2004 Jun;135(6):671-8. doi: 10.1016/j.surg.2003.11.014.

  PMID: 15179374 BACKGROUND

• Young VR, Ajami AM. Glutamine: the emperor or his clothes? J Nutr. 2001 Sep;131(9 Suppl):2449S-59S; discussion 2486S-7S. doi: 10.1093/jn/131.9.2449S.

  PMID: 11533293 BACKGROUND

• Herndon DN, Tompkins RG. Support of the metabolic response to burn injury. Lancet. 2004 Jun 5;363(9424):1895-902. doi: 10.1016/S0140-6736(04)16360-5.

  PMID: 15183630 BACKGROUND

MeSH Terms

Conditions

Burns; Hyperphagia

Interventions

Parenteral Nutrition; Nutritional Support; Glutamine; Glutamic Acid

Condition Hierarchy (Ancestors)

Wounds and Injuries; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutrition Therapy; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Glutamates; Amino Acids, Acidic; Amino Acids, Dicarboxylic; Excitatory Amino Acids

Study Officials

• Ronald G Tompkins, MD, ScD

  MGH, Shriners Burn Hospital-Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

US (1)