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

NCT00591071 | Unknown Phase 3 DMC

• 1 other identifier: 432
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hyperglycemia; Critically Ill Patients

Keywords

hyperglycemia; insulin treatment; intensive care; hypoglycemia; mechanical ventilation; critically ill patients

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Length of hospital stay

Secondary Outcomes (4)

• incidence of severe hypoglycemia (below 2.2 mmol/l)

  lenght of insulin administration in ICU

• ICU mortality

  Length of ICU stay

• Quality of obtained glycemic control in the 2 arms of the study

  Length of Continuous Insulin treatment

• Incidence of neuromyopathy in the ICU

  Length of ICU stay

Study Arms (2)

B

ACTIVE COMPARATOR

Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L

Other: Conventional glycemic control

A

EXPERIMENTAL

Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L

Other: Strict glycemic control

Interventions

Strict glycemic control OTHER

Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level below 6.1 mmol/L

A

Conventional glycemic control OTHER

Continuous intravenous insulin treatment (NOVORAPID) according to an algorithm to maintain glucose level at 11 mmol/L

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age
• requiring mechanical ventilation with an expected duration above 48 hours

You may not qualify if:

• 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)
• patient or next of kind refusal of study participation
• pregnant women

Sponsors & Collaborators

• Poissy-Saint Germain Hospital: lead

Study Sites (2)

Medico-surgical ICU Louise Michel Hospital

Évry, 91014 Cedex, France

NOT YET RECRUITING

Medico-surgical ICU Poissy Saint Germain Hospital

Poissy, 78300, France

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jean-Claude Lacherade, MD

  Medico-surgical ICU Poissy Saint Germain Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Claude Lacherade, MD

CONTACT

33 1 39 27 52 02; jclacherade@chi-poissy-st-germain.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: January 11, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 14, 2008

Record last verified: 2007-12

Locations

FR (2)