Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/09/2013
Date assigned
08/10/2013
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
irinaluc@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ioana Marina Grintescu

ORCID ID

Contact details

Calea Floreasca
Nr. 4-8
Bucharest
011123
Romania
-
ioana.grintescu@rospen.ro

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Importance of glutamine supplementation in critical patients: a randomised controlled study

Acronym

Study hypothesis

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

Ethics Committee of the Emergency Clinical Hospital Bucharest; Date: 02/10/2013

Study design

Randomised controlled open-label study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

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

01/01/2010

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

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

01/01/2010

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Romania

Trial participating centre

Calea Floreasca, Nr. 4-8
Bucharest
011123
Romania

Sponsor information

Organisation

Clinical Emergency Hospital Bucharest (Romania)

Sponsor details

c/o Dr. Irina Luca Vasiliu
Calea Floreasca no.8
sector 1
Bucharest
020904
Romania

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initated and funded (Romania)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24931756

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.