Alterations in Protein Synthesis Rates of Burn Patients Measured Over Time Using PET Scans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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

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Burn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

16 healthy subjects will be studied. Each patient will undergo one PET Scan to measure muscle protein synthesis rate.

PET Scans

Intervention Type PROCEDURE

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.

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.

PET Scans

Intervention Type PROCEDURE

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.

Interventions

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PET Scans

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.

Intervention Type PROCEDURE

Other Intervention Names

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PET Scan Muscle Protein Metabolism

Eligibility Criteria

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Inclusion Criteria

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.

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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes