Glutamine Supplementation in Critically Ill Patients With Severe Sepsis (CGH-GLU)

February 7, 2017 updated by: Changi General Hospital

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective

  • To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
  • Primary outcome : 28 day mortality , Development of infectious complications

  • Secondary outcomes

    • Duration of mechanical ventilation
    • Length of stay in ICU
    • Length of stay in hospital
    • 3 month survival status and resumption of baseline activities
    • 6 month survival status and resumption of baseline activities

Study Design

  • Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis

  • Randomisation

    • A centralised randomisation system at SCRI (Singapore Clinical Research institute)
    • Allocation will be random and concealed, and will be blinded to everyone except the pharmacist at each site, who will be responsible for preparing and delivering them to the ICU in a blinded fashion.

  • Intervention

    • 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.

  • Cointerventions

    • 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.

Execution of study protocol

  • The managing ICU team will be responsible in identifying patients that meet the inclusion and exclusion criteria and will inform the site research coordination

  • The site research coordinator will be responsible for the following

    • Obtaining consent from relatives of the patients
    • Informing the site pharmacist about the recruited patients
    • Follow study patients prospectively while in the ICU, hospital and post discharge at 3 and 6 months.
    • Completing the case report from for each study participant
    • Submitting case report forms, completed and interim reports, to coordinating statistical team

  • Pharmacist

    • Site pharmacist to liase with SCRI on randomised patients status (treatment vs. placebo)
    • Prepare the intervention treatment and placebo
    • Deliver the treatment and placebo to the respective patients.

  • Nurses

    • Responsible for administering the delivered medications
    • Ensure and documenting compliance with administration, reasons for interruptions and documenting adverse reactions.
    • Liasing with the site research coordinator daily regarding the above.
    • Liasing with the site research coordinator on transfer, discharge or death of study participants

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • All adult patients (>18 years old) admitted to ICU plus

  • Severe sepsis defined as 2 or more or the following

    • Temperature >38oC or < 36oC
    • Heart rate > 90 beats per min
    • Respiratory rate >20 breaths per min or PaCO2 <32 mmHg

    • White cell count > 12,000/microL or < 4,000/microL

      • PLUS presence or presumed presence of infection
      • PLUS evidence of organ dysfunction as defined by either of the following
      • Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) < 65 mm Hg; or on vasopressors
      • Hyperlactatemia: Serum lactate >/= 2 mmol/L (18 mg/dL)
      • Renal: Acute increase in serum creatinine to > 176.8 mmol/L (2.0 mg/dL) or urine output < 0.5 mL/kg/hour for > 2 hours
      • Lung: Acute lung injury with PaO2/FiO2 </=300mmHg
      • Liver: Acute increase in bilirubin to >/= 34.2 umol/L (2 mg/dL)
      • Thrombocytopenia: Acute decrease in platelet count to < 100,000 cells/mm3
      • Coagulopathy: International normalized ratio (INR) > 1.5 or a partial thromboplastin time (aPTT) > 60 secs which is not due to anticoagulant therapy
    • Exclusion criteria
  • >48hr from admission to ICU
  • Patients who are not expected to survive >48hrs by the managing team
  • Refusal to consent to study
  • Allergic to glutamine or its constituents
  • Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition
  • Patients with a primary admission diagnosis of burns (>30% body surface area)
  • Patients whose weight <40kg or >200kg
  • Previous randomization to this study
  • Enrolled in a related ICU interventional nutrition study
  • Pregnant patients or lactating mothers with the intent to breastfeed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
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.
ACTIVE_COMPARATOR: Glutamine
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mortality
Time Frame: 28 day
28 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Occurrence of new infections
Time Frame: Initial hospital admission, assessed up to 130 days.
Initial hospital admission, assessed up to 130 days.
ICU length of stay (LOS)
Time Frame: From date of ICU admission to date of transferred to General Ward or date of death from any cause, whichever came first, assessed up to 21 days.
From date of ICU admission to date of transferred to General Ward or date of death from any cause, whichever came first, assessed up to 21 days.
Hospital LOS
Time Frame: From date of recruitment to date of discharged from hospital or date of transferred to other hospitals or date of death from any cause, whichever came first, assessed up to 130 days.
From date of recruitment to date of discharged from hospital or date of transferred to other hospitals or date of death from any cause, whichever came first, assessed up to 130 days.
Duration of mechanical ventilation
Time Frame: During period of ICU stay, assessed up to 14 days.
During period of ICU stay, assessed up to 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changi General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Singhealth Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vijo Poulose, Changi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTC1000338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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