NCT00922714

Brief Summary

This is a prospective double-blinded placebo-controlled block randomized study in intensive care patients comparing intravenous glutamine supplementation to placebo. The hypothesis is an improvement of clinical outcome. The primary endpoint is a reduction in the Sequential Organ Failure Assessment (SOFA) score on day 7 of treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

3.6 years

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

ICU Patients

Keywords

GlutamineICU patientsCritically illNutrition

Outcome Measures

Primary Outcomes (1)

  • A reduction in SOFA-score

    Day 7 of treatment

Secondary Outcomes (4)

  • Mortality

    ICU stay and 6 months

  • Length of ICU stay

    ICU stay

  • Organ failure free days

    ICU stay

  • Reduction in SOFA-score

    Day 10 of treatment

Study Arms (2)

Glutamine

EXPERIMENTAL

Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)

Drug: Glutamine

Control

PLACEBO COMPARATOR

saline

Drug: saline (placebo)

Interventions

GlutamineDRUG

Intravenous glutamine supplementation (0.285 g/kg body weight/24 h)

Also known as: L-alanyl-L-glutamine, Dipeptiven
Glutamine
saline (placebo)DRUG

NaCl 0.9 g/L

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admission to the ICU
  • decision to give the patient full nutrition
  • APACHE II score \> 10 at admission
  • age 18-85 years

You may not qualify if:

  • readmission to the ICU after a previous ICU-stay in which the patient has been included into the study
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Karolinska University Hospital Huddinge

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Critical Illness

Interventions

GlutaminealanylglutamineSodium Chloride

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, NeutralChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jan Wernerman, MD, PhD

    Dept Anesthesiology and Intensive Care Medicine, KArolinska University Hospital Huddinge, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

October 1, 2003

Primary Completion

May 1, 2007

Study Completion

August 1, 2009

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

SE(1)