Informations générales (source: ClinicalTrials.gov)
Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY) (INSUREA)
Interventional
Phase 3
Poissy-Saint Germain Hospital (Voir sur ClinicalTrials)
janvier 2008
septembre 2010
29 juin 2024
During hospitalization in the intensive care unit (ICU), the occurrence of a blood
glucose imbalance is frequent and associated with increased mortality. These observations
have resulted in the hypothesis that intensive insulin therapy designed to control blood
glucose would improve the prognosis of patients admitted into the ICU. In a prospective,
randomized, single center study in a surgical ICU during which the majority of patients
had undergone cardiac surgery, intensive insulin therapy with the objective to maintain
glycemia below 110 mg/dl (6.1 mmol/L) provided a significant reduction in ICU mortality
and hospital mortality compared to a group with a glycemic objective of 200 mg/dl.
In a recent published article, the beneficial effect of intensive insulin therapy seems
less obvious in a randomized single center study in a medical ICU. One of the potential
factors limiting the impact of a therapeutic strategy like this one is the absence of
achieving strict glycemic control for all patients on intensive insulin therapy.
Additionally, the implementation of such a therapeutic strategy results in an increased
risk of hypoglycemia, the consequences of which on morbidity remain unclear.
The aim of our study is to determine, in a mixed population of medical and surgical
patients admitted to the ICU, requiring artificial ventilation with a expected duration
above 48 hours, the impact of effective strict glycemic control (<6,1 mmol/l) compared to
a conventional glycemic control (<11mmol/l) on hospital mortality.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI POISSY ST-GERMAIN | Jean-Claude Lacherade, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Medico-surgical ICU Louise Michel Hospital - 91014 Cedex - Evry - France | Andry Van de Louw, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- over 18 years of age
- requiring mechanical ventilation with an expected duration above 48 hours
- over 18 years of age
- requiring mechanical ventilation with an expected duration above 48 hours
- admission for cardiac arrest
- admission for an attempt of drug autolysis or acute drunkenness
- admission for hyperosmolar and/or ketoacidosis coma
- admission for massive cerebral hemorrhage
- admission from an another ICU
- admission after surgery without any other organ failure than respiratory support
(with FiO2 below 50% and PeeP below 5cm H2O)
- inclusion in an another interventional study
- patient or next of kind refusal of study participation
- pregnant women