Impact of 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted in ICU
Information source: Poissy-Saint Germain Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperglycemia; Critically Ill Patients
Intervention: Strict glycemic control (Other); Conventional glycemic control (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: Poissy-Saint Germain Hospital Official(s) and/or principal investigator(s): Jean-Claude Lacherade, MD, Principal Investigator, Affiliation: Medico-surgical ICU Poissy Saint Germain Hospital
Overall contact: Jean-Claude Lacherade, MD, Phone: 33 1 39 27 52 02, Email: jclacherade@chi-poissy-st-germain.fr
Summary
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.
Clinical Details
Official title: Multicentre Randomized Trial Assessing the Impact of Maintaining 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted to the ICU (INSUREA STUDY)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hospital mortality
Secondary outcome: incidence of severe hypoglycemia (below 2.2 mmol/l)ICU mortality Quality of obtained glycemic control in the 2 arms of the study Incidence of neuromyopathy in the ICU
Detailed description:
In both randomization arms, continuous insulin infusion will be used via the venous route
of administration. Rapid action insulin Novorapid HM (Novo Nordisk, Copenhagen, Denmark)
will be used.
ICU patient management requires many intravenously administered treatments in a limited
number of venous lines (catecholamines, sedation, feeding, vascular filling, antiotics…).
This situation does not enable to dedicate an infusion line for the intravenous
administration of insulin. Despite continuous administration of insulin infusion, the
concomitant administration of other treatments in the same infusion line obviously leads to
significant variations in the flow of insulin actually delivered, which can lead to
variations in blood glucose and adjustments secondary to the inappropriate dose of insulin.
To limit this phenomenon, an OCTOPUS (Vygon, Ecouen, France) type infusion connector will be
added. The infusion connector is made of 2 infusion lines one of which will be exclusively
dedicated to insulin therapy subsequently limiting the risk of variations in insulin
administration flow.
The determination of the number of subjects to include was carried out by using a 45%
hospital mortality hypothesis in the conventional glycemic control group. and a 32 %
hospital mortality hypothesis in the strict glycemic control group.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- over 18 years of age
- requiring mechanical ventilation with an expected duration above 48 hours
Exclusion Criteria:
- 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
Locations and Contacts
Jean-Claude Lacherade, MD, Phone: 33 1 39 27 52 02, Email: jclacherade@chi-poissy-st-germain.fr
Medico-surgical ICU Louise Michel Hospital, Evry 91014 Cedex, France; Not yet recruiting Andry Van de Louw, MD, Email: andry.vandelouw@ch-sud-francilien.fr Andry Van de Louw, MD, Principal Investigator
Medico-surgical ICU Poissy Saint Germain Hospital, Poissy 78300, France; Recruiting Jean-Claude Lacherade, MD, Phone: 33 1 39 27 54 55, Email: jclacherade@chi-poissy-st-germain.fr Jean-Claude Lacherade, MD, Principal Investigator
Additional Information
Starting date: January 2008
Last updated: February 13, 2008
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