Multiple TraumaPhase 3GLINTNCT01240291
The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition
A Phase 3 study testing Dipeptiven and normal saline in people with Multiple Trauma and Critically Ill, run by Royal Brisbane and Women's Hospital at 1 site in Australia.
Trial summary
The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Trauma, Critically Ill
- What is being tested?
- Dipeptiven and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-58 years
- Patients admitted with a diagnosis of multiple trauma requiring enteral feeding for > 48 hours
- Expected length of stay in ICU > 48 hours
- Has a functional access for enteral tube feeding and a central access for administration of test solution
- Negative Beta HCG (pregnancy test) in females (18-60 years)
Who cannot join
- Age < 18 years
- Significant hepatic failure (Patients with Childs C Cirrhosis)
- Severe renal failure (estimated glomerular filtration rate [eGFR] < 50 ml/min)
- Patients with severe metabolic acidosis (pH <7.35)
- Not expected to be in the ICU > 48 hours (due to imminent death)
- Unable to tolerate enteral nutrition within 72 hours
Show all 9Show fewer
- Enrolment in other ICU intervention study if contraindicated
- Patients in whom parenteral nutrition is required from the outset
- Absolute contraindication to enteral nutrition
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4029
About this study
Official title: Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial
The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes
Read the detailed description
Trauma Patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. Glutamine supplementation to parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. A number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. However, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. Therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes.
Our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.
- Conditions
- Multiple Trauma, Critically Ill
- Being tested
- Dipeptiven, normal saline
- Keywords
- glutamine, trauma, alanyl-glutamine
- Medical subject headings
- Multiple Trauma, Critical Illness, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DipeptivenDietary supplement
Also called Fresenius Kabi
Intravenous alanyl-glutamine (0.5 g/kg body weight; i.e. 0.35 g L-glutamine / kg body weight; continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks.
normal salineDietary supplement
Also called NaCl
0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| alanyl-glutamine | Experimental | Intravenous alanyl-glutamine (0.5 g/kg body weight/day) Receives: Dietary Supplement: Dipeptiven |
| normal saline | Placebo comparator | Intravenous placebo (normal saline; 0.9 %) Receives: Dietary Supplement: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.
The change in daily total SOFA score plotted each day over 10 days, where we will compare the regression slope between the two arms of the study.
Measured: daily until discharge from intensive care unit, death or maximum duration of 10 days.
Secondary outcomes (8)
The change in daily total Sequential Organ failure Assessment Score (SOFA) on the last day of treatment as a measure of severity of organ dysfunction.
Measured: Last day of treatment
Number of infections that are documented during intensive care unit stay.
Measured: During intensive care unit stay.
Number of deaths occuring on or before day 60.
Measured: within 60 days.
Length of stay in intensive care unit.
Measured: At discharge from intensive care unit.
Length of stay in hospital.
Length of stay in hospital (if delayed discharge due to placement problems, will record from the date the patient is regarded as fit for discharge by medical staff).
Measured: At hospital discharge.
Number of days on mechanical ventilation.
Measured: during intensive care unit stay.
Number of days of antibiotic use during intensive care unit stay.
Measured: during intensive care unit stay.
Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).
Measured: every 2 days until discharge from the intensive care unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple TraumaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brisbane and Women's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ruqaiya Al-Balushi, Royal Brisbane and Women's Hospital
- Investigators
- Jeffrey Lipman, MBBCh, MD, Principal investigator, Royal Brisbane & Women's Hpsoital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240291
- Sponsor's protocol ID
- HREC/10/QRBW/131
- Acronym
- GLINT
- Status last verified
- May 2012
- First submitted
- 1 Nov 2010
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Al Balushi RM, Paratz JD, Cohen J, Banks M, Dulhunty J, Roberts JA, Lipman J. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial. BMJ Open. 2011 Nov 14;1(2):e000334. doi: 10.1136/bmjopen-2011-000334. Print 2011.
PubMed 22102646
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01240291
- Acronym / sponsor ID
- GLINT / HREC/10/QRBW/131
- Conditions
- Multiple Trauma, Critically Ill
- Keywords
- glutamine, trauma, alanyl-glutamine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Royal Brisbane and Women's HospitalOther government
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 15 Nov 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.
The purpose of this trial is to investigate if pharmacologically safe dose intravenous glutamine dipeptide supplementation to multiple trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications, and other secondary outcomes
Detailed description
Trauma Patients are characterized by alteration in the immune response, increased exposure to infectious complications, sepsis, and consequently organ failure and death. Glutamine supplementation to parenteral nutrition is one of the nutritional interventions that have been proven to be associated with improved survival rate, decreased infectious morbidity, costs, intensive care unit, and hospital length of stay. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. A number of trials investigated the beneficial effects of intravenous alanyl-glutamine supplementation in critically ill patients receiving enteral nutrition. However, these trials were: pilot trials, investigated surrogate outcomes, or supplementation was for a short period of time. Therefore, a well designed trial is needed to investigate the effect of intravenous alanyl-glutamine supplementation in critically ill patients with multiple trauma receiving enteral nutrition on major clinical outcomes.
Our hypothesis is that trauma patients receiving standard enteral nutrition supplemented with intravenous alanyl-glutamine will demonstrate improved clinical outcomes compared to patients receiving standard enteral nutrition without supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alanyl-glutamine | Experimental | Dietary Supplement: DipeptivenIntravenous alanyl-glutamine (0.5 g/kg body weight/day) |
| normal saline | Placebo comparator | Dietary Supplement: normal salineIntravenous placebo (normal saline; 0.9 %) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-58 years
- Patients admitted with a diagnosis of multiple trauma requiring enteral feeding for > 48 hours
- Expected length of stay in ICU > 48 hours
- Has a functional access for enteral tube feeding and a central access for administration of test solution
- Negative Beta HCG (pregnancy test) in females (18-60 years)
Key exclusion criteria (9 listed)
- Age < 18 years
- Significant hepatic failure (Patients with Childs C Cirrhosis)
- Severe renal failure (estimated glomerular filtration rate [eGFR] < 50 ml/min)
- Patients with severe metabolic acidosis (pH <7.35)
- Not expected to be in the ICU > 48 hours (due to imminent death)
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 |
|---|---|---|
| DipeptivenAlso: Fresenius KabiIntravenous alanyl-glutamine (0.5 g/kg body weight; i.e. 0.35 g L-glutamine / kg body weight; continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks. | Dietary supplement | alanyl-glutamine |
| normal salineAlso: NaCl0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks | Dietary supplement | normal saline |
Primary outcome
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.
Time frame: daily until discharge from intensive care unit, death or maximum duration of 10 days.
The change in daily total SOFA score plotted each day over 10 days, where we will compare the regression slope between the two arms of the study.
8 secondary outcomes
The change in daily total Sequential Organ failure Assessment Score (SOFA) on the last day of treatment as a measure of severity of organ dysfunction.
Time frame: Last day of treatment
Number of infections that are documented during intensive care unit stay.
Time frame: During intensive care unit stay.
Number of deaths occuring on or before day 60.
Time frame: within 60 days.
Length of stay in intensive care unit.
Time frame: At discharge from intensive care unit.
Length of stay in hospital.
Time frame: At hospital discharge.
Number of days on mechanical ventilation.
Time frame: during intensive care unit stay.
Number of days of antibiotic use during intensive care unit stay.
Time frame: during intensive care unit stay.
Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).
Time frame: every 2 days until discharge from the intensive care unit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
- Derived from this study: PubMed 22102646Al Balushi RM, Paratz JD, Cohen J, Banks M, Dulhunty J, Roberts JA, Lipman J. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial. BMJ Open. 2011 Nov 14;1(2):e000334. doi: 10.1136/bmjopen-2011-000334. Print 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.
Jeffrey Lipman, MBBCh, MD principal investigator
Royal Brisbane & Women's Hpsoital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dipeptiven and normal saline in people with Multiple Trauma and Critically Ill, run by Royal Brisbane and Women's Hospital at 1 site in Australia.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 May 2012. 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 Australia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruqaiya M Al-Balushi, MSc (+ 61 7 3346 5105, ruqaiya.albalushi@uqconnect.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days. (time frame: daily until discharge from intensive care unit, death or maximum duration of 10 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240291, which also lists 1 linked publication.
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 24 May 2012.