TraumaPhase 1NCT00067132
Adjuvant Nutrition for Critically Ill Trauma Patients
A Phase 1 study testing Juven (nutritional), HMB (nutritional) in people with Trauma, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Of the four million trauma cases each year that will require hospitalization, 200,000 will be classified as severe trauma. During the hospital stay, malnutrition is a major complication in about 50% of the patient population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trauma
- What is being tested?
- Juven (nutritional), HMB (nutritional)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Genetic or immune disorder
- Known hepatitis
- 3rd degree burns involving more than 15% of the body
- Use of other investigational drugs
- Steroid use
Show all 11Show fewer
- Malignancy
- HIV
- Congestive heart failure
- Inflammatory bowel disease
- Implanted pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
United States1 site
University Medical Trauma Center/UNSOM
Las Vegas, Nevada, 89102
About this study
Of the four million trauma cases each year that will require hospitalization, 200,000 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 (HMB/Arg/Gln)or 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 HMB/Arg/Gln 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 (n=100) will be recruited at the time of admittance to the Trauma ICU with an ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB alone, or 3)standard 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.
Read the 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 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.
- Conditions
- Trauma
- Being tested
- Juven (nutritional), HMB (nutritional)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juven (nutritional), HMB (nutritional)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- John A Rathmacher, Ph.D., Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067132
- Sponsor's protocol ID
- 1R43DK061818 (completed)
- Other IDs
- MTI-UNR-001, 1R43DK061818
- Status last verified
- Jan 2010
- First submitted
- 11 Aug 2003
- Last updated
- 14 Jan 2010
- Results posted
- No
Publications
May PE, Barber A, D'Olimpio JT, Hourihane A, Abumrad NN. Reversal of cancer-related wasting using oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine. Am J Surg. 2002 Apr;183(4):471-9. doi: 10.1016/s0002-9610(02)00823-1.
PubMed 11975938Clark RH, Feleke G, Din M, Yasmin T, Singh G, Khan FA, Rathmacher JA. Nutritional treatment for acquired immunodeficiency virus-associated wasting using beta-hydroxy beta-methylbutyrate, glutamine, and arginine: a randomized, double-blind, placebo-controlled study. JPEN J Parenter Enteral Nutr. 2000 May-Jun;24(3):133-9. doi: 10.1177/0148607100024003133.
PubMed 10850936Panton LB, Rathmacher JA, Baier S, Nissen S. Nutritional supplementation of the leucine metabolite beta-hydroxy-beta-methylbutyrate (hmb) during resistance training. Nutrition. 2000 Sep;16(9):734-9. doi: 10.1016/s0899-9007(00)00376-2.
PubMed 10978853Nissen S, Sharp R, Ray M, Rathmacher JA, Rice D, Fuller JC Jr, Connelly AS, Abumrad N. Effect of leucine metabolite beta-hydroxy-beta-methylbutyrate on muscle metabolism during resistance-exercise training. J Appl Physiol (1985). 1996 Nov;81(5):2095-104. doi: 10.1152/jappl.1996.81.5.2095.
PubMed 8941534Williams JZ, Abumrad N, Barbul A. Effect of a specialized amino acid mixture on human collagen deposition. Ann Surg. 2002 Sep;236(3):369-74; discussion 374-5. doi: 10.1097/00000658-200209000-00013.
PubMed 12192323
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Nutrition for Critically Ill Trauma Patients
- ClinicalTrials.gov ID
- NCT00067132
- Acronym / sponsor ID
- 1R43DK061818 (completed)
- Conditions
- Trauma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Mar 2003
- First posted
- 13 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Of the four million trauma cases each year that will require hospitalization, 200,000 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 (HMB/Arg/Gln)or 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 HMB/Arg/Gln 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 (n=100) will be recruited at the time of admittance to the Trauma ICU with an ISS of greater than 18. Patients who meet the inclusion/exclusion criteria will be randomized to receive either 1) standard tube feed plus HMB/Arg/Gln, 2) standard tube feed plus HMB alone, or 3)standard 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- Pregnant
- Genetic or immune disorder
- Known hepatitis
- 3rd degree burns involving more than 15% of the body
- Use of other investigational drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Juven (nutritional), HMB (nutritional) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Background: PubMed 11975938May PE, Barber A, D'Olimpio JT, Hourihane A, Abumrad NN. Reversal of cancer-related wasting using oral supplementation with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and glutamine. Am J Surg. 2002 Apr;183(4):471-9. doi: 10.1016/s0002-9610(02)00823-1.
- Background: PubMed 10850936Clark RH, Feleke G, Din M, Yasmin T, Singh G, Khan FA, Rathmacher JA. Nutritional treatment for acquired immunodeficiency virus-associated wasting using beta-hydroxy beta-methylbutyrate, glutamine, and arginine: a randomized, double-blind, placebo-controlled study. JPEN J Parenter Enteral Nutr. 2000 May-Jun;24(3):133-9. doi: 10.1177/0148607100024003133.
- Background: PubMed 10978853Panton LB, Rathmacher JA, Baier S, Nissen S. Nutritional supplementation of the leucine metabolite beta-hydroxy-beta-methylbutyrate (hmb) during resistance training. Nutrition. 2000 Sep;16(9):734-9. doi: 10.1016/s0899-9007(00)00376-2.
- Background: PubMed 8941534Nissen S, Sharp R, Ray M, Rathmacher JA, Rice D, Fuller JC Jr, Connelly AS, Abumrad N. Effect of leucine metabolite beta-hydroxy-beta-methylbutyrate on muscle metabolism during resistance-exercise training. J Appl Physiol (1985). 1996 Nov;81(5):2095-104. doi: 10.1152/jappl.1996.81.5.2095.
- Background: PubMed 12192323Williams JZ, Abumrad N, Barbul A. Effect of a specialized amino acid mixture on human collagen deposition. Ann Surg. 2002 Sep;236(3):369-74; discussion 374-5. doi: 10.1097/00000658-200209000-00013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rathmacher, Ph.D. principal investigator
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Juven (nutritional), HMB (nutritional) in people with Trauma, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067132, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.