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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00253279
Collaborator
National Institute of General Medical Sciences (NIGMS) (NIH)
64
1
2
31.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PET Scans

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

Study Type:
Observational
Anticipated Enrollment :
64 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Study Start Date :
Nov 1, 2009
Anticipated Primary Completion Date :
Jan 1, 2010
Anticipated Study Completion Date :
Jan 1, 2010

Arms and Interventions

Arm Intervention/Treatment
1

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

Procedure: 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.
Other Names:
  • PET Scan
  • Muscle Protein Metabolism
  • 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.

    Procedure: 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.
    Other Names:
  • PET Scan
  • Muscle Protein Metabolism
  • Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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:
      Inclusion Criteria:

      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Massachusetts General Hospital Boston Massachusetts United States 02114

      Sponsors and Collaborators

      • Massachusetts General Hospital
      • National Institute of General Medical Sciences (NIGMS)

      Investigators

      • Principal Investigator: Ronald T Tompkins, MD, ScD, Massachusetts General Hospital, Shriners Burn Hospital- Boston

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00253279
      Other Study ID Numbers:
      • 2005-P-001510
      • G P50 GM021700-28
      First Posted:
      Nov 15, 2005
      Last Update Posted:
      Aug 13, 2009
      Last Verified:
      Aug 1, 2009
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Aug 13, 2009