Plain English Summary
Background and study aims
Rapid onset of resistance to insulin is an important part of stress metabolism in major trauma patients. Recent studies confirm the role of amino acids (especially glutamine) in glucose transportation and the benefits of amino acid supplementation . The purpose of this study is to find out about the incidence of high blood glucose, the need for insulin therapy and the average daily requirement of insulin in critical trauma patients with amino acid (Dipeptiven) supplementation versus standard nutritional support.
Who can participate?
Adult multiple trauma patients can participate in the study.
What does the study involve?
Patients are randomly divided into two groups. Patients in the first group received amino acid supplementation, while patients in the second group received standard nutritional support.
What are the possible benefits and risks of participating?
The benefits for patients are better control of glucose level and less need for insulin, meaning a lower risk of low blood glucose. There are no studies or reports on possible side effects of amino acid supplementation in critical patients.
Where is the study run from?
The study included patients admitted in the intensive care unit (ICU) of the Emergency Clinical Hospital Bucharest, Romania.
When is the study starting and how long is it expected to run for?
The study started in January 2010 and ran for a period of one year.
Who is funding the study?
This is an investigator initiated and funded study (Romania).
Who is the main contact?
Dr Irina Luca Vasiliu
Prof Ioana Marina Grintescu
Importance of glutamine supplementation in critical patients: a randomised controlled study
The purpose of this study is to evaluate the incidence of hyperglycemic episodes, the need for insulin therapy and the mean daily requirement of insulin in critical polytraumatised patients with parenteral glutamine dipeptides (Dipeptiven) supplementation versus standard nutritional support.
Ethics Committee of the Emergency Clinical Hospital Bucharest; Date: 02/10/2013
Randomised controlled open-label study
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Parenteral glutamine dipeptides supplementation, hyperglycemic episodes, multiple trauma
82 multiple trauma patients were randomised to two groups of 41, independent of sex, age (20-60 years old), injury severity score (25-50).
Group 1: Patients received parenteral supplementation with glutamine dipeptides 0.5 g/kg/day
Group 2: Patients received an isocaloric, isoproteic and isoglucidic nutritional support
The supplementation of glutamine began simultaneously with nutritional support and continued for at least 7 days. None of the patients started oral feeding in this period, the nutritional support was mainly parenteral with the least minimal enteral feeding. During the 6-day period we determined glycaemia every 6 hours, targeting to maintain values between 140 and 180 mg/dl.
Primary outcome measures
1. Plasmatic glycemia every 4-6 hours for a 6-day period using descriptive statistics
2. Daily insulin requirements using the same method above
Secondary outcome measures
Amount of exogenous insulin administered in this 6-day period by ANOVA analysis
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Young patients (over 18 years)
2. With multiple traumatic lesions
3. With an ISS over 22
4. Without significant comorbidities
5. Subjects admitted to the intensive care unit (ICU) for one year
Target number of participants
We aimed to include 100 young patients (over 18 years)
Participant exclusion criteria
1. BMI >30 kg/m^2
2. Renal or hepatic dysfunction
3. Diabetes mellitus
4. Reduced prior nutritional intake
5. Oral intake in the first 7 days
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Calea Floreasca, Nr. 4-8
Investigator initated and funded (Romania)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24931756