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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Page 1 of 2 (5 locations)

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