BurnNCT00253279
Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans
An observational study of Burn, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Our specific aim is to gain an understanding of protein synthesis rates in burn patients at various times during their injury and recovery by using PET scans. This will be compared with healthy volunteer controls. We hope this will help optimize nutrition and care regimens for future burn patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn
- What is being tested?
- PET Scans
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2010
- Phase
- Observational
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and burn patients
Who may be able to join
- FOR HEALTHY VOLUNTEERS
- Healthy males and females 18-70 years of age.
- Laboratory results within MGH-accepted normal range.
- Within 20% of the ideal weight for their height.
- Supine and standing blood pressure within the range of 110/60 to 150/90 mm Hg
- Heart rate within the range of 46-90 beats/minute after 5 minutes of rest.
Show all 12Show fewer
- Subjects <40 years old with HCT >=24, age 40-60 with HCT >=27, age 60-70 with HCT >=30.
- FOR BURN SUBJECTS:
- Burn Injury of >=5 % TBSA from any cause.
- 18 -70 years of age
- Stable hemodynamic and cardiopulmonary states as judged by the attending surgeons in the burn unit.
- Patient who is capable of giving full informed consent.
Who cannot join
- FOR HEALTHY SUBJECTS Clinical evidence of physical or mental disease.
- Clinically significant abnormality of the laboratory tests.
- Known drug or alcohol dependence.
- History of drug allergy
- Taking standard prescription drugs within two weeks or investigational drugs within four weeks prior to the PET scan
- Diabetes mellitus and other metabolic endocrine disorders Pregnant or lactating
- FOR BURN SUBJECTS:
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mary-Liz c Bilodeau, MS, 617-726-8766, mbilodeau@partners.org
Yong-Ming Yu, MD, PhD, 617-724-7766, yyu@partners.org
About this study
Official title: A Quantitative Study of the Metabolic Alterations in Protein Synthesis Rate That Occur in Burn Patients Over the Time Course of Their Injury Using Positron Emission Tomography.
Our specific aim is to gain an understanding of protein synthesis rates in burn patients at various times during their injury and recovery by using PET scans. This will be compared with healthy volunteer controls. We hope this will help optimize nutrition and care regimens for future burn patients.
Read the detailed description
The purpose of this study is to understand how muscles are built up and broken down (metabolism) in both burn patients and healthy people.The studies will help us understand how muscle metabolism is different for burn patients and healthy subjects. We hope to find ways to help the body of a burn victim heal without losing too much muscle.
Protein is an important part of our daily diet. Normally, the body breaks down the protein we eat into smaller pieces called amino acids. It uses the amino acids to make its own proteins. It uses these proteins to heal wounds, fight infections, and provide energy.
After a burn injury, the body speeds up the pace of its life activities. It needs more energy just to stay alive and recover from the burn. The body often gets the extra energy it needs by breaking the protein in muscles down into amino acids. The amino acids are then made into new proteins. If too much muscle is broken down, it is harder for the body to function. This can make recovery slower or possibly lead to death.
For Healthy Volunteers, this study will require no more than 6 hours of time in total. This time will be spread out over two visits, a Screening Visit and a Scan Visit.
For Burn Patients, this study will require no more than 14 hours total. This time will be spread out over four visits-a screening visit and a maximum of 3 scan visits. A total of three PET scans will be done over a 2 year period.
- Conditions
- Burn
- Being tested
- PET Scans
- Keywords
- Protein Synthesis Rate, Burn Injury, PET Scan
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET ScansProcedure or surgery
Also called PET Scan, Muscle Protein Metabolism
Healthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 16 healthy subjects will be studied. Each patient will undergo one PET Scan to measure muscle protein synthesis rate. Receives: Procedure: PET Scans | |
| 2 | 48 burn patients will be studied. Each patient will have a maximum of 3 PET Scans, which will be done at different times during the first 24 months after injury. A maximum of 2 of these scans will be done while they are inpatient; one after discharge. Receives: Procedure: PET Scans |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2009
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Investigators
- Ronald T Tompkins, MD, ScD, Principal investigator, Massachusetts General Hospital, Shriners Burn Hospital- Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253279
- Sponsor's protocol ID
- 2005-P-001510
- Other IDs
- G P50 GM021700-28
- Status last verified
- Aug 2009
- First submitted
- 11 Nov 2005
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischman AJ, Hsu H, Carter EA, Yu YM, Tompkins RG, Guerrero JL, Young VR, Alpert NM. Regional measurement of canine skeletal muscle blood flow by positron emission tomography with H2(15)O. J Appl Physiol (1985). 2002 Apr;92(4):1709-16. doi: 10.1152/japplphysiol.00445.2001.
PubMed 11896041Fischman AJ, Yu YM, Livni E, Babich JW, Young VR, Alpert NM, Tompkins RG. Muscle protein synthesis by positron-emission tomography with L-[methyl-11C]methionine in adult humans. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):12793-8. doi: 10.1073/pnas.95.22.12793.
PubMed 9788993Hsu H, Yu YM, Babich JW, Burke JF, Livni E, Tompkins RG, Young VR, Alpert NM, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine. Proc Natl Acad Sci U S A. 1996 Mar 5;93(5):1841-6. doi: 10.1073/pnas.93.5.1841.
PubMed 8700846Carter EA, Yu YM, Alpert NM, Bonab AA, Tompkins RG, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine: effects of transamination and transmethylation. J Trauma. 1999 Aug;47(2):341-5. doi: 10.1097/00005373-199908000-00021.
PubMed 10452471
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative Study of the Metabolic Alterations in Protein Synthesis Rate That Occur in Burn Patients Over the Time Course of Their Injury Using Positron Emission Tomography.
- ClinicalTrials.gov ID
- NCT00253279
- Acronym / sponsor ID
- 2005-P-001510
- Conditions
- Burn
- Keywords
- Protein Synthesis Rate, Burn Injury, PET Scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 15 Nov 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.
Our specific aim is to gain an understanding of protein synthesis rates in burn patients at various times during their injury and recovery by using PET scans. This will be compared with healthy volunteer controls. We hope this will help optimize nutrition and care regimens for future burn patients.
Detailed description
The purpose of this study is to understand how muscles are built up and broken down (metabolism) in both burn patients and healthy people.The studies will help us understand how muscle metabolism is different for burn patients and healthy subjects. We hope to find ways to help the body of a burn victim heal without losing too much muscle.
Protein is an important part of our daily diet. Normally, the body breaks down the protein we eat into smaller pieces called amino acids. It uses the amino acids to make its own proteins. It uses these proteins to heal wounds, fight infections, and provide energy.
After a burn injury, the body speeds up the pace of its life activities. It needs more energy just to stay alive and recover from the burn. The body often gets the extra energy it needs by breaking the protein in muscles down into amino acids. The amino acids are then made into new proteins. If too much muscle is broken down, it is harder for the body to function. This can make recovery slower or possibly lead to death.
For Healthy Volunteers, this study will require no more than 6 hours of time in total. This time will be spread out over two visits, a Screening Visit and a Scan Visit.
For Burn Patients, this study will require no more than 14 hours total. This time will be spread out over four visits-a screening visit and a maximum of 3 scan visits. A total of three PET scans will be done over a 2 year period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: PET Scans16 healthy subjects will be studied. Each patient will undergo one PET Scan to measure muscle protein synthesis rate. |
| 2 | – | Procedure: PET Scans48 burn patients will be studied. Each patient will have a maximum of 3 PET Scans, which will be done at different times during the first 24 months after injury. A maximum of 2 of these scans will be done while they are inpatient; one after discharge. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and burn patients
Key inclusion criteria (12 listed)
- FOR HEALTHY VOLUNTEERS
- Healthy males and females 18-70 years of age.
- Laboratory results within MGH-accepted normal range.
- Within 20% of the ideal weight for their height.
- Supine and standing blood pressure within the range of 110/60 to 150/90 mm Hg
Key exclusion criteria (8 listed)
- FOR HEALTHY SUBJECTS Clinical evidence of physical or mental disease.
- Clinically significant abnormality of the laboratory tests.
- Known drug or alcohol dependence.
- History of drug allergy
- Taking standard prescription drugs within two weeks or investigational drugs within four weeks prior to the PET scan
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 |
|---|---|---|
| PET ScansAlso: PET Scan, Muscle Protein MetabolismHealthy volunteers will undergo one PET Scan; bur patients will undergo a maximum of 3 PET scans over 2 years after injury; a maximum of 2 will be done while inpatient; one after d/c. | Procedure or surgery | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
- Background: PubMed 11896041Fischman AJ, Hsu H, Carter EA, Yu YM, Tompkins RG, Guerrero JL, Young VR, Alpert NM. Regional measurement of canine skeletal muscle blood flow by positron emission tomography with H2(15)O. J Appl Physiol (1985). 2002 Apr;92(4):1709-16. doi: 10.1152/japplphysiol.00445.2001.
- Background: PubMed 9788993Fischman AJ, Yu YM, Livni E, Babich JW, Young VR, Alpert NM, Tompkins RG. Muscle protein synthesis by positron-emission tomography with L-[methyl-11C]methionine in adult humans. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):12793-8. doi: 10.1073/pnas.95.22.12793.
- Background: PubMed 8700846Hsu H, Yu YM, Babich JW, Burke JF, Livni E, Tompkins RG, Young VR, Alpert NM, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine. Proc Natl Acad Sci U S A. 1996 Mar 5;93(5):1841-6. doi: 10.1073/pnas.93.5.1841.
- Background: PubMed 10452471Carter EA, Yu YM, Alpert NM, Bonab AA, Tompkins RG, Fischman AJ. Measurement of muscle protein synthesis by positron emission tomography with L-[methyl-11C]methionine: effects of transamination and transmethylation. J Trauma. 1999 Aug;47(2):341-5. doi: 10.1097/00005373-199908000-00021.
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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 T Tompkins, MD, ScD principal investigator
Massachusetts General Hospital, 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?
An observational study of Burn, 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 12 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Aug 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253279, which also lists 4 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 Aug 2009.