KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Study Overview
=================
Brief Summary
-----------------
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Detailed Description
-----------------
In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Official Title
-----------------
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Drug: intensive insulin therapy to maintain normoglycemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults admitted to ICU and anticipated to require intensive care for at least a few days Exclusion Criteria: Expected short ICU stay Therapy restricted upon admission Surgical ICU patients Other studies Below 18 years Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intensive insulin therapy to maintain normoglycemia|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilatory support-dependency |  |  | 
| stay in Intensive Care Unit (ICU) |  |  | 
| stay in hospital |  |  | 
| organ failure |  |  | 
| morbidity |  |  | 
| a long-term follow up is planned to take place 6 and 12 months after hospital discharge |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
critical illness, intensive care, outcome, insulin, blood glucose