Intensive Care Clinical Trial
Official title:
Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).
Status | Completed |
Enrollment | 168 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Criteria 1, 2 and 3 must be present: 1. Clinical patients admitted to an Intensive Care Unit 2. At least one blood glucose measurement >= 150 mg/dL (capilar, venous or arterial blood) 3. At least one of the following: 1. Patient on mechanical ventilation for an acute process, with expected duration of mechanical ventilation of at least 24 hours 2. Polytrauma patients 3. Severe burn patients 4. Systemic Inflammatory Response Syndrome (modified criteria), with at least three of the following: core temperature >=38°C or <=36°C; heart rate >=90 beats/min, except in patients with a medical condition or receiving a medication known to prevent tachycardia; respiratory heart rate >= 20 breaths/min or a PaCO2 <=32mmHg, or the use of mechanical ventilation for an acute process; white-cell count of >=12.000/mm3 or <=4.000/mm3 or a differential count showing >10% percent immature neutrophils Exclusion Criteria: - Age < 21 years - Surgical patients (surgery less than 24hs before admission to ICU) - Diabetic ketoacidosis - Non-ketotic hyperosmolar state - Patients with defined diagnosis of brain death - Moribund state in which death is perceived to be imminent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Complexo Hospitalar UNIMED | Joinville | Santa Catarina |
Brazil | Hospital Dona Helena | Joinville | Santa Catarina |
Brazil | Hospital Regional Sao Jose | Joinville | Santa Catarina |
Brazil | Hospital Estadual Mario Covas | Santo Andre | Sao Paulo |
Brazil | Hospital Israelita Albert Einstein | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy: mean of patients' median blood glucose during ICU stay | ICU Stay | ||
Primary | Safety: incidence of hypoglycemia (=40 mg/dL)during ICU stay | ICU stay | ||
Secondary | Death from any cause | ICU and in-hospital | ||
Secondary | ICU and hospital length of stay | ICU and in-hospital | ||
Secondary | Five-day variation in SOFA score | Five days | ||
Secondary | 90-day health status | 90 days | ||
Secondary | Days on mechanical ventilation | |||
Secondary | Initiation of dialysis | |||
Secondary | Days on antibiotics | |||
Secondary | Days on inotropic of vasopressor support | |||
Secondary | Necessity of red blood cell transfusions | |||
Secondary | Bilirubin peak | |||
Secondary | Platelets through |
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