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Impact of two glucose control regimens by insulin on hospital mortality in intensive care unit patients (INSUREA Study) - INSUREA

Conditions
hyperglycemia in critical care unit patients
MedDRA version: 9.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)
Registration Number
EUCTR2007-000436-74-FR
Lead Sponsor
Poissy Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adults patients admitted in intensive car unit and requiring a mechanical ventilation with a duration estimated above 48 hours.
Consent obtained from the patient or the next of kin
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Transfer from an another Intensive Care Unit,
Admission for cardiac arrest or drug overdose or acido-cetosis
Pregnancy
Consent non obtained
Inclusion in an another clinical study

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: reduction of hospital mortality;Secondary Objective: reduction of intensive care mortality, incidence of severe hypoglycemia (defined by a glycemia below 2.2 mmol/l, incidence of critical illness neuromuscular syndromes;Primary end point(s): Reduction of Hospital Mortality
Secondary Outcome Measures
NameTimeMethod
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