CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Glutamine +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048994
NCT03048994N/ACompleted

A Randomized Controlled Trial of Glutamine Supplementation in Critically Ill Adults With Severe Sepsis: A Pilot Study

Changi General Hospital·interventional·Posted Feb 9, 2017·Updated Feb 9, 2017

In Brief

A clinical study evaluating Glutamine and Placebo for Severe Sepsis. Completed, enrolled 39 participants across 1 site.

Detailed Summary

Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. But there is lack of evidence to recommend the use of intravenous glutamine supplementation in this population group. A randomized controlled trial which is adequately powered will resolve this issue and can be included in future international nutrition guidelines for the critically ill. This pilot study is done prior to a proposed local multi-center study to investigate the effects of glutamine supplementation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Sepsis
CountriesSingapore

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.4 years ago

Interventions

Glutaminedietary

* Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours. * IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital. * An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.

Placebodietary

* Nutritional support will be continued as per managing ICU team discretion. * Management of severe sepsis will be continued as per managing ICU team discretion. * Weaning patients from mechanical ventilation will be done as per managing ICU team discretion. * To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.