Status:
COMPLETED
Efficacy and Safety of Three Insulin Protocols in Medical Intensive Care Unit Patients
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conditions:
Intensive Care
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).
Detailed Description
Strict glycemic control has been recommended for critically ill patients. However, its implementation may face difficulties with increased nursing workload, inadequate glucose control and higher risk ...
Eligibility Criteria
Inclusion
- Criteria 1, 2 and 3 must be present:
- Clinical patients admitted to an Intensive Care Unit
- At least one blood glucose measurement \>= 150 mg/dL (capilar, venous or arterial blood)
- At least one of the following:
- Patient on mechanical ventilation for an acute process, with expected duration of mechanical ventilation of at least 24 hours
- Polytrauma patients
- Severe burn patients
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00410852
Start Date
May 1 2005
End Date
March 1 2007
Last Update
November 2 2007
Active Locations (5)
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1
Complexo Hospitalar UNIMED
Joinville, Santa Catarina, Brazil
2
Hospital Dona Helena
Joinville, Santa Catarina, Brazil
3
Hospital Regional Sao Jose
Joinville, Santa Catarina, Brazil
4
Hospital Estadual Mario Covas
Santo André, São Paulo, Brazil