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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00253279
First received: November 11, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Burn
Procedure: PET Scans
Phase 1

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Estimated Enrollment: 64
Study Start Date: November 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy subjects and burn patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253279

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Mary-Liz c Bilodeau, MS    617-726-8766    mbilodeau@partners.org   
Contact: Yong-Ming Yu, MD, PhD    617-724-7766    yyu@partners.org   
Principal Investigator: Alan J Fischman, MD, PhD         
Sub-Investigator: Colleen M Ryan, MD         
Sub-Investigator: Robert L Sheridan, MD         
Sub-Investigator: Shawn P Fagan, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ronald T Tompkins, MD, ScD Massachusetts General Hospital, Shriners Burn Hospital- Boston
  More Information

Additional Information:
Publications:
Responsible Party: Ronald G. Tompkins, MD, ScD, Chief, Burn Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00253279     History of Changes
Other Study ID Numbers: 2005-P-001510, G P50 GM021700-28
Study First Received: November 11, 2005
Last Updated: August 12, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Protein Synthesis Rate
Burn Injury
PET Scan

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014