NCT00780520

Brief Summary

Glutamine levels decrease during severe sepsis; this may be associated with increased mortality. The investigators tested the effects of glutamine supplementation on systemic inflammation in a human sepsis model. The investigators found that glutamine levels drops significantly during experimentally induced systemic inflammation. However, glutamine did not affect the degree of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

October 24, 2008

Last Update Submit

October 24, 2008

Conditions

SepsisSystemic Inflammation

Keywords

glutamine inflammation HSP70 sepsis

Outcome Measures

Primary Outcomes (1)

  • Plasma-levels of cytokines

Secondary Outcomes (1)

  • Heat shock protein -70 production from BMNCs

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: alanine-glutamine infusion

2

PLACEBO COMPARATOR
Dietary Supplement: alanine-glutamine infusion

Interventions

alanine-glutamine infusionDIETARY_SUPPLEMENT
12

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young males

You may not qualify if:

  • Any kind of acute or chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Inflammation and Metabolism, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • Andreasen AS, Pedersen-Skovsgaard T, Mortensen OH, van Hall G, Moseley PL, Pedersen BK. The effect of glutamine infusion on the inflammatory response and HSP70 during human experimental endotoxaemia. Crit Care. 2009;13(1):R7. doi: 10.1186/cc7696. Epub 2009 Jan 27.

    PMID: 19173710DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

June 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations

DK(1)