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Impact of 2 Blood Glucose Levels on Hospital Mortality in Patients Admitted in ICU (INSUREA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Poissy-Saint Germain Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier:
NCT00591071
First received: December 20, 2007
Last updated: February 13, 2008
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Critically Ill Patients
 Other: Strict glycemic control
Other: Conventional glycemic control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Poissy-Saint Germain Hospital:

Primary Outcome Measures:
  • Hospital mortality [ Time Frame: Length of hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of severe hypoglycemia (below 2.2 mmol/l) [ Time Frame: lenght of insulin administration in ICU ] [ Designated as safety issue: Yes ]
  • ICU mortality [ Time Frame: Length of ICU stay ] [ Designated as safety issue: No ]
  • Quality of obtained glycemic control in the 2 arms of the study [ Time Frame: Length of Continuous Insulin treatment ] [ Designated as safety issue: No ]
  • Incidence of neuromyopathy in the ICU [ Time Frame: Length of ICU stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: January 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L
 Other: Conventional glycemic control
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L
Experimental: A
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L
 Other: Strict glycemic control
Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591071

Contacts
Contact: Jean-Claude Lacherade, MD 33 1 39 27 52 02 jclacherade@chi-poissy-st-germain.fr

Locations
France
Medico-surgical ICU Louise Michel Hospital Not yet recruiting
Evry, France, 91014 Cedex
Contact: Andry Van de Louw, MD         andry.vandelouw@ch-sud-francilien.fr    
Principal Investigator: Andry Van de Louw, MD            
Medico-surgical ICU Poissy Saint Germain Hospital Recruiting
Poissy, France, 78300
Contact: Jean-Claude Lacherade, MD     33 1 39 27 54 55     jclacherade@chi-poissy-st-germain.fr    
Principal Investigator: Jean-Claude Lacherade, MD            
Sponsors and Collaborators
Poissy-Saint Germain Hospital
Investigators
Principal Investigator: Jean-Claude Lacherade, MD Medico-surgical ICU Poissy Saint Germain Hospital
  More Information

No publications provided

Responsible Party: Jean-Claude Lacherade MD, Poissy Saint Germain Hospital
ClinicalTrials.gov Identifier: NCT00591071     History of Changes
Other Study ID Numbers: 432
Study First Received: December 20, 2007
Last Updated: February 13, 2008
Health Authority: France: Ministry of Health

Keywords provided by Poissy-Saint Germain Hospital:
hyperglycemia
insulin treatment
intensive care
 hypoglycemia
mechanical ventilation
critically ill patients

Additional relevant MeSH terms:
Critical Illness
Hyperglycemia
Disease Attributes
 Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013