Trauma Patients in ICUNCT01219608
Iranian Intensive Care Unit (ICU) Glutamine Study
A study testing Glutamine 0.5 g/kg/day, Glutamine 1 g/kg/day and Enteral Nutrition in people with Trauma Patients in ICU, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma Patients in ICU
- What is being tested?
- Glutamine 0.5 g/kg/day, Glutamine 1 g/kg/day and Enteral Nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Jun 2011
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- No corticosteroids use
- No history of heart, liver and kidney diseases
- Nutrition through nasogastric or orogastric
Who cannot join
- Patients who will not tolerate enteral nutrition for more than 48 hours
- Patients who are NPO and nutritional support has not started
- Lactating and pregnant women
- Kidney failure during the study
- A history of glutamin supplement use before the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.
- Conditions
- Trauma Patients in ICU
- Being tested
- Glutamine 0.5 g/kg/day, Glutamine 1 g/kg/day, Enteral Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine 0.5 g/kg/dayDietary supplement
Glutamine 0.5 g/kg/day
Glutamine 1 g/kg/dayDietary supplement
Glutamine 1 g/kg/day
Enteral NutritionDietary supplement
Ordinary Enteral Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Glutamine 0.5 g/kg/day | Active comparator | Not described Receives: Dietary Supplement: Glutamine 0.5 g/kg/day |
| Glutamine 1 g/kg/day | Active comparator | Not described Receives: Dietary Supplement: Glutamine 1 g/kg/day |
| Enteral Nutrition | Placebo comparator | Not described Receives: Dietary Supplement: Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection Probability Score
Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
Systemic Inflammatory Response Syndrome
Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
Secondary outcomes (6)
Prealbumin
Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
CRP
CRP will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
Serum prealbumin
Prealbumin will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after the intervention
Length of stay (LOS)
LOS will be measured and will be compared to the baseline after 10 days of the intervention
Bed sores
Bed sores will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
Mechanical ventilation
Mean mechanical ventilation need will be measured and will be compared to the baseline after 10 days of the intervention
Measured: 10 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma Patients in ICUStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219608
- Sponsor's protocol ID
- eums1388
- Status last verified
- Oct 2010
- First submitted
- 6 Oct 2010
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iranian Intensive Care Unit (ICU) Glutamine Study
- ClinicalTrials.gov ID
- NCT01219608
- Acronym / sponsor ID
- eums1388
- Conditions
- Trauma Patients in ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Oct 2010 (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.
This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glutamine 0.5 g/kg/day | Active comparator | Dietary Supplement: Glutamine 0.5 g/kg/day |
| Glutamine 1 g/kg/day | Active comparator | Dietary Supplement: Glutamine 1 g/kg/day |
| Enteral Nutrition | Placebo comparator | Dietary Supplement: Enteral Nutrition |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60
- No corticosteroids use
- No history of heart, liver and kidney diseases
- Nutrition through nasogastric or orogastric
Key exclusion criteria (5 listed)
- Patients who will not tolerate enteral nutrition for more than 48 hours
- Patients who are NPO and nutritional support has not started
- Lactating and pregnant women
- Kidney failure during the study
- A history of glutamin supplement use before the study
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 |
|---|---|---|
| Glutamine 0.5 g/kg/dayGlutamine 0.5 g/kg/day | Dietary supplement | Glutamine 0.5 g/kg/day |
| Glutamine 1 g/kg/dayGlutamine 1 g/kg/day | Dietary supplement | Glutamine 1 g/kg/day |
| Enteral NutritionOrdinary Enteral Nutrition | Dietary supplement | Enteral Nutrition |
Primary outcome
Infection Probability Score
Time frame: 10 days after intervention
Infection Probability Score will be measured and will be compared to the baseline after 10 days of the intervention
Systemic Inflammatory Response Syndrome
Time frame: 10 days after intervention
Systemic Inflammatory Response Syndrome will be measured and will be compared to the baseline after 10 days of the intervention
6 secondary outcomes
Prealbumin
Time frame: 10 days after intervention
CRP
Time frame: 10 days after intervention
Serum prealbumin
Time frame: 10 days after the intervention
Length of stay (LOS)
Bed sores
Time frame: 10 days after intervention
Mechanical ventilation
Time frame: 10 days after intervention
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 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine 0.5 g/kg/day, Glutamine 1 g/kg/day and Enteral Nutrition in people with Trauma Patients in ICU, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 5 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 Jun 2011. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
What does the primary outcome measure?
Infection Probability Score (time frame: 10 days after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2011.