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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-P-001946 |
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State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
We hypothesize that:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Burn Patients receiving at least 3 days of parenteral feeding on routine formula |
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| 2 | Experimental | Burn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula. |
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| 3 | Experimental | Burn patients receiving at least 3 days of enteral feeding on routine formula. |
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| 4 | Experimental | Burn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
One or more of the following:
Inhalation Injury
Resting Energy Expenditure of >15% of the predicted Basal Metabolic Rate Using Harris-Benedict.
Receiving Enteral or Parental Nutritional Support
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald G Tompkins, MD, ScD | MGH, Shriners Burn Hospital-Boston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Burn Unit | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15179374 | Background | 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. | |
| 11533293 | 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. |
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| Stable isotope tracer study | Dietary Supplement | 7 hours of primed constant infusion |
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| Stable isotope study | Dietary Supplement | 7 hours of primed constant infusion of stable isotope tracers. |
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| Stable isotope tracer study | Dietary Supplement | 7 hours of primed constant stable isotope tracer infusion. |
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| Stable isotope tracer study | Dietary Supplement | 7 hours primed constant infusion of stable isotope tracer study |
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| 15183630 | 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. |
| ID | Term |
|---|---|
| D002056 | Burns |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D018529 | Nutritional Support |
| D005973 | Glutamine |
| D018698 | Glutamic Acid |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D044623 | Nutrition Therapy |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
| D021542 | Amino Acids, Neutral |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000600 | Amino Acids, Dicarboxylic |
| D018846 | Excitatory Amino Acids |
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