BurnsNCT00181753
Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
A study testing standard vs. glutamine enteral or parenteral feeding., Stable isotope tracer study and Stable isotope study in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- standard vs. glutamine enteral or parenteral feeding., Stable isotope tracer study and Stable isotope study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Burn Unit
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
We hypothesize that:
- 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.
- 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.
- 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.
- Conditions
- Burns
- Being tested
- standard vs. glutamine enteral or parenteral feeding., Stable isotope tracer study, Stable isotope study
- Keywords
- glutamine metabolic kinetics, glutamate metabolic kinetics, enteral nutrition, parenteral nutrition, burn injury, stable isotopes
- Medical subject headings
- Burns, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard vs. glutamine enteral or parenteral feeding.Drug
Also called Nutritional Support, Glutamine, Glutamate, Amino Acide
Patient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements.
Stable isotope tracer studyDietary supplement
Also called Glutamine, Stable isotope study
7 hours of primed constant infusion
Stable isotope studyDietary supplement
Also called Stable isotopes, Glutamine
7 hours of primed constant infusion of stable isotope tracers.
Stable isotope tracer studyDietary supplement
Also called Stable isotope tracers, Glutamine
7 hours of primed constant stable isotope tracer infusion.
Stable isotope tracer studyDietary supplement
Also called Glutamine, Stable isotope tracers
7 hours primed constant infusion of stable isotope tracer study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Burn Patients receiving at least 3 days of parenteral feeding on routine formula Receives: 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. Receives: 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. Receives: 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. Receives: Drug: standard vs. glutamine enteral or parenteral feeding.; Dietary Supplement: Stable isotope tracer study; Dietary Supplement: Stable isotope study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days and above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Why it stopped: State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Ronald G Tompkins, MD, ScD, Principal investigator, MGH, Shriners Burn Hospital-Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181753
- Sponsor's protocol ID
- 2P50GM021700-27A1
- Other IDs
- 2004-P-001946
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15179374Young 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.
PubMed 11533293Herndon 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.
PubMed 15183630
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Glutamate and Glutamine Metabolism in Burn Patients Receiving Enteral or Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT00181753
- Acronym / sponsor ID
- 2P50GM021700-27A1
- Conditions
- Burns
- Keywords
- glutamine metabolic kinetics, glutamate metabolic kinetics, enteral nutrition, parenteral nutrition, burn injury, stable isotopes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: State of Mass. tightened regulations for making intravenous solutions for research subjects. Study was withdrawn and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Nov 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We hypothesize that:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: standard vs. glutamine enteral or parenteral feeding., Dietary Supplement: Stable isotope tracer study, Dietary Supplement: Stable isotope studyBurn Patients receiving at least 3 days of parenteral feeding on routine formula |
| 2 | Experimental | Drug: standard vs. glutamine enteral or parenteral feeding., Dietary Supplement: Stable isotope tracer study, Dietary Supplement: Stable isotope studyBurn patients receiving at least 3 days on parenteral feeding on glutamine enriched formula. |
| 3 | Experimental | Drug: standard vs. glutamine enteral or parenteral feeding., Dietary Supplement: Stable isotope tracer study, Dietary Supplement: Stable isotope studyBurn patients receiving at least 3 days of enteral feeding on routine formula. |
| 4 | Experimental | Drug: standard vs. glutamine enteral or parenteral feeding., Dietary Supplement: Stable isotope tracer study, Dietary Supplement: Stable isotope studyBurn patients receiving at least 3 days of enteral feeding on glutamine-enriched formula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Pre-existing:
- Thyroid disease
- Congestive Heart Failure (Ejection fraction <20%)
- Malignancy currently under treatment
- Medical conditions requiring glucocorticoid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard vs. glutamine enteral or parenteral feeding.Also: Nutritional Support, Glutamine, Glutamate, Amino AcidePatient in each group will continue on the same diet for > 3 days before we conduct stable isotope tracer measurements. | Drug | 1, 2, 3, 4 |
| Stable isotope tracer studyAlso: Glutamine, Stable isotope study7 hours of primed constant infusion | Dietary supplement | 1, 2, 3, 4 |
| Stable isotope studyAlso: Stable isotopes, Glutamine7 hours of primed constant infusion of stable isotope tracers. | Dietary supplement | 1, 2, 3, 4 |
| Stable isotope tracer studyAlso: Stable isotope tracers, Glutamine7 hours of primed constant stable isotope tracer infusion. | Dietary supplement | 1, 2, 3, 4 |
| Stable isotope tracer studyAlso: Glutamine, Stable isotope tracers7 hours primed constant infusion of stable isotope tracer study | Dietary supplement | 1, 2, 3, 4 |
Primary outcome
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.
Time frame: 3 days and above
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
- Background: PubMed 15179374Sheridan 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.
- Background: PubMed 11533293Young 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.
- Background: PubMed 15183630Herndon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G Tompkins, MD, ScD principal investigator
MGH, Shriners Burn Hospital-Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard vs. glutamine enteral or parenteral feeding., Stable isotope tracer study and Stable isotope study in people with Burns, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 days and above). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00181753, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.