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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000436-74-FR
Enrollment
Unknown
Registered
2007-10-04
Start date
2007-11-27
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

hyperglycemia in critical care unit patients MedDRA version: 9.1 Level: HLGT Classification code 10018424 Term: Glucose metabolism disorders (incl diabetes mellitus)

Interventions

Trade Name: Insuline aspartate Product Name: NOVORAPID Pharmaceutical Form: Solution for injection INN or Proposed INN: insuline aspartate Concentration unit: U/ml unit(s)/millilitre Concentration typ

Sponsors

Poissy Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

Countries

France

Outcome results

None listed

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