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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alanyl-glutamine | Experimental | Intravenous alanyl-glutamine (0.5 g/kg body weight/day) |
|
| normal saline | Placebo Comparator | Intravenous placebo (normal saline; 0.9 %) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dipeptiven | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | daily until discharge from intensive care unit, death or maximum duration of 10 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Last day of treatment | |
| Number of infections that are documented during intensive care unit stay. | During intensive care unit stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruqaiya M Al-Balushi, MSc | Contact | + 61 7 3346 5105 | ruqaiya.albalushi@uqconnect.edu.au | |
| Jennifer Paratz, PhD | Contact | + 61 7 36361980 | j.paratz@uq.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Lipman, MBBCh, MD | Royal Brisbane & Women's Hpsoital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane & Women's Hospital | Recruiting | Brisbane | Queensland | 4029 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22102646 | Derived | 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. |
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| ID | Term |
|---|---|
| D009104 | Multiple Trauma |
| D016638 | Critical Illness |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C054122 | alanylglutamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| normal saline | Dietary Supplement | 0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks |
|
|
| Number of deaths occuring on or before day 60. | within 60 days. |
| Length of stay in intensive care unit. | 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). | At hospital discharge. |
| Number of days on mechanical ventilation. | during intensive care unit stay. |
| Number of days of antibiotic use during intensive care unit stay. | during intensive care unit stay. |
| Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA). | every 2 days until discharge from the intensive care unit. |