Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

Hospital Pablo Tobón Uribe1 site in 1 country504 target enrollmentJuly 2003

ConditionsCritical Illness Hyperglycemia Insulin Resistance

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Critical Illness
Sponsor: Hospital Pablo Tobón Uribe
Enrollment: 504
Locations: 1
Primary Endpoint: Mortality in the next 28 days
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Detailed Description

Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only. Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

September 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Pablo Tobón Uribe

Eligibility Criteria

Inclusion Criteria

•15 years of age or older,
•Probability of staying in critical care for more than 48 hours,
•Agreement with the informed consent.

Exclusion Criteria

•Pregnancy,
•Participating in other trials,
•Diabetic keto-acidosis or diabetic hyperosmolar state,
•Do-not-resuscitate orders,
•Reentry to the critical care unit of the same patient.

Outcomes

Primary Outcomes

Mortality in the next 28 days

Secondary Outcomes

Days of ventilatory support
Acute renal failure requiring dialysis or hemofiltration
Mortality during intensive care
Mortality overall in-hospital
Mortality among patients who remained in the intensive care unit for more than five days
Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
Length of stay in the unit
The median number of red-cell transfusions
SOFA score
Critical-illness polyneuropathy