MedTrace Logo

Glutamine Supplementation in Critically Ill Patients With Severe Sepsis

NCT03048994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2017-02-09

No results posted yet for this study

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.

Conditions

  • Severe Sepsis

Interventions

DIETARY_SUPPLEMENT

Glutamine

* 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.

DIETARY_SUPPLEMENT

Placebo

* 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.

Sponsors & Collaborators

  • Singhealth Foundation

    collaborator OTHER_GOV

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Vijo Poulose · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048994 on ClinicalTrials.gov