Importance of glutamine supplementation in critical patients
| ISRCTN | ISRCTN71592366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71592366 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/09/2013
- Registration date
- 08/10/2013
- Last edited
- 24/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
irinaluc@yahoo.com
Contact information
Scientific
Calea Floreasca, Nr. 4-8
Bucharest
011123
Romania
| ioana.grintescu@rospen.ro |
Study information
| Study design | Randomised controlled open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Importance of glutamine supplementation in critical patients: a randomised controlled study |
| Study objectives | 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 approval(s) | Ethics Committee of the Emergency Clinical Hospital Bucharest; Date: 02/10/2013 |
| Health condition(s) or problem(s) studied | Parenteral glutamine dipeptides supplementation, hyperglycemic episodes, multiple trauma |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | We aimed to include 100 young patients (over 18 years) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Romania
Study participating centre
011123
Romania
Sponsor information
Hospital/treatment centre
c/o Dr. Irina Luca Vasiliu
Calea Floreasca no.8, sector 1
Bucharest
020904
Romania
"ROR" |
https://ror.org/03grprm46 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No |
Editorial Notes
24/02/2016: Publication reference added.
