Adjuvant Nutrition for Critically Ill Trauma Patients
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Study Start Date:||March 2003|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067132
|United States, Nevada|
|University Medical Trauma Center/UNSOM|
|Las Vegas, Nevada, United States, 89102|
|Principal Investigator:||John A Rathmacher, Ph.D.||Metabolic Technologies Inc.|