Tight Glycemic Control in Critical Care Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Illness, Hyperglycemia, Insulin Resistance

Intervention / Treatment
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* Behavioral: Tight control of blood glucose levels
* Behavioral: Conventional control of glucose levels


Participation Criteria
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Eligibility Criteria
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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, Moribund Do-not-resuscitate orders, Reentry to the critical care unit of the same patient.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tight control of blood glucose levels|nan|
|Behavioral: Conventional control of glucose levels|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in the next 28 days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 
| Days of ventilatory support |  |  | 
| Acute renal failure requiring dialysis or hemofiltration |  |  | 
| The median number of red-cell transfusions |  |  | 
| SOFA score |  |  | 
| Critical-illness polyneuropathy |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy