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

Phase 1

• Conditions: Critical Illness

• Registration Number: EUCTR2006-000576-33-GB
• Lead Sponsor: St Helens & Knowsley Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-17
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Change of glutamine concentration in serum and muscle between both groups.<br>Are the observed effects influenced by age.