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

NCT00591071 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2008-02-14

No results posted yet for this study

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

Interventions

OTHER

Strict glycemic control

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

OTHER

Conventional glycemic control

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

Sponsors & Collaborators

  • Poissy-Saint Germain Hospital

    lead OTHER

Principal Investigators

  • Jean-Claude Lacherade, MD · Medico-surgical ICU Poissy Saint Germain Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00591071 on ClinicalTrials.gov