Pilot Study to investigate the role of Glutamine in the early protective stress response - Glutamine Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000576-33-GB

Enrollment

Registered

2006-05-17

Start date

2006-06-13

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Interventions

Product Name: Dipeptiven Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: In

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All admissions to intensive care less than 24 hours from admission with an illness severity APACHE II score >10. Aged >18 years Willing to consent or with consent given by relative or legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Coagulopathy, defined as 1. INR>1.5 2. Platelet count <100 Bleeding disorder Hepatic impairment defined as a total billrubin concentration of more than 45 micromol/l or a more than 5 fold increase of Alanin amino transferase (ALT) above normal. <18 years of age Unwilling to consent or consent withheld by relative or legal representative Pregnancy Expected to be discharged within 48 hours from admission as judged by the Consultant in charge at the day of screening Expected to die within 48 hours from admission as judged by the Consultant in charge at the day of screening Malignant disease if not surgically resected Unable to perform biopsy on clinical grounds On total parenteral nutrition as it contains Glutamine

Design outcomes

Primary

Measure	Time frame
Main Objective: Change in Heat Shock Protein concentration in serum and muscle after Glutamine administation. Change of glutamine concentration in serum and muscle after Glutamine substitution.;Secondary Objective: Effect on Hospital Mortality. Effect on the length of stay in Intensive Care. Effect on the time spent on a Ventilator. Effect on the numbers of infections while on Intensive Care and in hospital.;Primary end point(s): Change in HSP concentration in serum and muscle between both groups. Change of glutamine concentration in serum and muscle between both groups. Are the observed effects influenced by age.	—

Measure

Time frame

Main Objective: Change in Heat Shock Protein concentration in serum and muscle after Glutamine administation. Change of glutamine concentration in serum and muscle after Glutamine substitution.;Secondary Objective: Effect on Hospital Mortality. Effect on the length of stay in Intensive Care. Effect on the time spent on a Ventilator. Effect on the numbers of infections while on Intensive Care and in hospital.;Primary end point(s): Change in HSP concentration in serum and muscle between both groups. Change of glutamine concentration in serum and muscle between both groups. Are the observed effects influenced by age.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026