ClinicalTrials.Veeva

Menu

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

Mass General Brigham logo

Mass General Brigham

Status

Withdrawn

Conditions

Burns

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00181753
2P50GM021700-27A1
2004-P-001946

Details and patient eligibility

About

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.

Full description

We hypothesize that:

  1. Burn patients will experience an increased conversion of glutamine to glutamate and a decreased conversion of glutamate to glutamine as compared to healthy subjects. The net direction is from glutamine to glutamate in burn patients and would render glutamine as a conditionally essential amino acid.
  2. Because of the limited ability of liver to oxidize glutamate, it is possible that large doses of glutamine may cause increased gluconeogenesis in burn patients, thus aggravating the glucose homeostasis secondary to insulin resistance.
  3. Enterally and parenterally fed glutamine and glutamate have different metabolic fate in the splanchnic bed and peripheral regions, therefore the doses should be tailored according to the route of administration.

This study, using stable isotope tracers, aims to track the metabolic fate of glutamine and glutamate in body with the goal of enhancing nutritional efficiency.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • One or more of the following:

    • 5% 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 4 patient groups

1
Experimental group
Description:
Burn Patients receiving at least 3 days of parenteral feeding on routine formula
Treatment:
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Drug: standard vs. glutamine enteral or parenteral feeding.
Dietary Supplement: Stable isotope study
2
Experimental group
Description:
Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula.
Treatment:
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Drug: standard vs. glutamine enteral or parenteral feeding.
Dietary Supplement: Stable isotope study
3
Experimental group
Description:
Burn patients receiving at least 3 days of enteral feeding on routine formula.
Treatment:
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Drug: standard vs. glutamine enteral or parenteral feeding.
Dietary Supplement: Stable isotope study
4
Experimental group
Description:
Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula.
Treatment:
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Dietary Supplement: Stable isotope tracer study
Drug: standard vs. glutamine enteral or parenteral feeding.
Dietary Supplement: Stable isotope study

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems