Critically Ill Clinical Trial
— GLINTOfficial 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
Status | Recruiting |
Enrollment | 88 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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) Exclusion Criteria: - 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 - Enrolment in other ICU intervention study if contraindicated - Patients in whom parenteral nutrition is required from the outset - Absolute contraindication to enteral nutrition |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane & Women's Hospital | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
Royal Brisbane and Women's Hospital |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 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 | No | |
Secondary | Number of infections that are documented during intensive care unit stay. | During intensive care unit stay. | No | |
Secondary | Number of deaths occuring on or before day 60. | within 60 days. | No | |
Secondary | Length of stay in intensive care unit. | At discharge from intensive care unit. | No | |
Secondary | 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. | No |
Secondary | Number of days on mechanical ventilation. | during intensive care unit stay. | No | |
Secondary | Number of days of antibiotic use during intensive care unit stay. | during intensive care unit stay. | No | |
Secondary | 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. | No |
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