Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01240291




Registration number
NCT01240291
Ethics application status
Date submitted
1/11/2010
Date registered
15/11/2010
Date last updated
24/05/2012

Titles & IDs
Public title
The Clinical Role of Intravenous Glutamine in Trauma Patients Receiving Enteral Nutrition
Scientific title
Effect of Intravenous GLutamine Supplementation IN Trauma Patients Receiving Enteral Nutrition Study Protocol (GLINT Study): A Prospective, Blinded, Randomized, Placebo-controlled Clinical Trial
Secondary ID [1] 0 0
HREC/10/QRBW/131
Universal Trial Number (UTN)
Trial acronym
GLINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Trauma 0 0
Critically Ill 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Dipeptiven
Other interventions - normal saline

Experimental: alanyl-glutamine - Intravenous alanyl-glutamine (0.5 g/kg body weight/day)

Placebo Comparator: normal saline - Intravenous placebo (normal saline; 0.9 %)


Other interventions: Dipeptiven
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.

Other interventions: normal saline
0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in daily total Sequential Organ Failure Assessment Score (SOFA)each day over 10 days.
Timepoint [1] 0 0
daily until discharge from intensive care unit, death or maximum duration of 10 days.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Last day of treatment
Secondary outcome [2] 0 0
Number of infections that are documented during intensive care unit stay.
Timepoint [2] 0 0
During intensive care unit stay.
Secondary outcome [3] 0 0
Number of deaths occuring on or before day 60.
Timepoint [3] 0 0
within 60 days.
Secondary outcome [4] 0 0
Length of stay in intensive care unit.
Timepoint [4] 0 0
At discharge from intensive care unit.
Secondary outcome [5] 0 0
Length of stay in hospital.
Timepoint [5] 0 0
At hospital discharge.
Secondary outcome [6] 0 0
Number of days on mechanical ventilation.
Timepoint [6] 0 0
during intensive care unit stay.
Secondary outcome [7] 0 0
Number of days of antibiotic use during intensive care unit stay.
Timepoint [7] 0 0
during intensive care unit stay.
Secondary outcome [8] 0 0
Fat free mass and fat percentage as a measure of body composition by Bioelectric Impedance analysis (BIA).
Timepoint [8] 0 0
every 2 days until discharge from the intensive care unit.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2013
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Brisbane and Women's Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01240291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Lipman, MBBCh, MD
Address 0 0
Royal Brisbane & Women's Hpsoital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruqaiya M Al-Balushi, MSc
Address 0 0
Country 0 0
Phone 0 0
+ 61 7 3346 5105
Fax 0 0
Email 0 0
ruqaiya.albalushi@uqconnect.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01240291