Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067132
Status:
COMPLETED
Last Update Posted:
2010-01-14
First Post:
2003-08-11
Brief Title:
Adjuvant Nutrition for Critically Ill Trauma Patients
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Of the four million trauma cases each year that will require hospitalization 200000 will be classified as severe trauma During the hospital stay malnutrition is a major complication in about 50 of the patient population The result is muscle wasting which is a major risk factor for increased morbidity and mortality In this study we postulate that supplementation with beta-hydroxy-beta-methylbutyrate HMB arginine and glutamine HMBArgGlnor HMB alone to these severely traumatized patients can stem the loss of muscle tissue and whole body nitrogen and in turn decrease morbidity and mortality This hypothesis is based on two recent studies showing the same nutritional mixture of HMBArgGln can reverse the muscle wasting associated with AIDS and Cancer The hypermetabolic state seen in AIDS and cancer have a similar multifactorial etiology as seen in trauma There is an increase in the mobilization of fat and muscle increased or normal metabolic rate increased protein breakdown and an increased or normal glucose turnover In addition HMB alone has been shown to reduce nitrogen loss decrease muscle proteolysis and muscle damage within the first 48 hours to three weeks after initiating supplementation during a strenuous exercise program Male and female patients n100 will be recruited at the time of admittance to the Trauma ICU with an ISS of greater than 18 Patients who meet the inclusionexclusion criteria will be randomized to receive either 1 standard tube feed plus HMBArgGln 2 standard tube feed plus HMB alone or 3standard tube feed control in a double-blinded fashion Clinical outcomes measures will be assessed through out the hospital stay and on an outpatient basis at weeks 4 and 12 Muscle proteolysis and nitrogen economy will be evaluated on daily basis while in the hospital and after 4 weeks on an out patient basis If as expected Phase I results confirm the effectiveness of the nutrient mixture in trauma patients expanded multicenter studies will be proposed in Phase II
Detailed Description:
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 andor 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 01 3 7 and 14 White blood count number of confirmed infections and C-Reactive Protein levels will serve as proxies for immune status
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 andor 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 01 3 7 and 14 White blood count number of confirmed infections and C-Reactive Protein levels will serve as proxies for immune status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R43DK061818 | NIH | None | httpsreporternihgovquickSearch1R43DK061818 |
| MTI-UNR-001 | None | None | None |