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Phase 1
18 Years
80 Years
Not Enrolling
Both
Trauma

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Trial Information


OBJECTIVES:

To compare the effectiveness of immediate nutritional intervention with either HMB,
arginine, and glutamine or HMB alone with that of a placebo supplement in critically ill
trauma patients on:

- decreasing muscle protein turnover and nitrogen loss

- improving nutritional status,

- improving clinical outcomes,

- preventing total body weight and skeletal muscle loss and

- improving immune status

OUTLINE:

This is a double blind, placebo-controlled randomized clinical study. After receiving
informed consent for participation in the study from the next of kin, patients will be
randomly assigned to one of the 3 treatment arms:

Arm 1: Standard tube feed plus a nutritional supplement supplying 3 grams of HMB, 14 grams
of arginine and 14 grams of glutamine per day. The supplement will be divided into two
equal dosages with one dose being given in the morning and one dose given in the evening.

Arm 2: Standard tube feed plus a nutritional supplement supplying 3 grams of HMB. This
nutritional supplement will contain gelatin and non-essential amino acids to be
isonitrogenous with the supplement in Arm 1. The supplement will also be divided into two
equal dosages with one dose being given in the morning and one dose given in the evening.

Arm 3: Standard tube feed plus a nutritional supplement supplying a mixture of gelatin and
amino acids to be isonitrogenous with the supplement in Arm 1. The supplement will again be
divided into two equal dosages with one dose being given in the morning and one dose given
in the evening.

Patients will receive the nutritional supplements for a period of 4 weeks. If a patient
leaves the hospital or ICU before that time and/or discontinues the enteral nutrition
support, the supplements will be continued orally for the full 4-week period.

Several clinical outcome measures will be followed such as hospital length of stay, ICU
length of stay, mortality, number of ventilator days, and incidence of infectious
complications. Clinical outcomes will be assessed during the hospital stay and at 4 and 12
weeks. Muscle protein metabolism will be measured during the hospital stay and at 4 weeks.
Nutritional status while hospitalized will be assessed by serum pre-albumin levels on days
0,1, 3, 7, and 14. White blood count, number of confirmed infections and C-Reactive Protein
levels will serve as proxies for immune status.

Inclusion Criteria


Inclusion Criteria

- Critically injured trauma patients with an Injury Severity Score (ISS) >18

- Candidate for enteral feeding

- Life expectancy >48 hours

- Total Bilirubin less than or equal to 2.5 mg/dl

- Serum Creatinine less than 3.0 mg/dl.

- Must be able to start supplements within 72 h

- Patient must reside in geographical area of Las Vegas, Nevada

Exclusion Criteria

- Pregnant

- Genetic or immune disorder

- Known hepatitis

- 3rd degree burns involving more than 15% of the body

- Use of other investigational drugs

- Steroid use

- Malignancy

- HIV

- Congestive heart failure

- Inflammatory bowel disease

- Implanted pacemaker or defibrillator

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

John A Rathmacher, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Metabolic Technologies Inc.

Authority:

United States: Federal Government

Study ID:

1R43DK061818 (completed)

NCT ID:

NCT00067132

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Trauma
  • Wounds and Injuries

Name

Location

University Medical Trauma Center/UNSOMLas Vegas, Nevada  89102