Efficacy and Safety of Three Insulin Protocols in Medical Intensive Care Unit Patients

Not Applicable

Completed

• Conditions: Intensive Care
• Interventions: Procedure: Computer-assisted IV insulin infusion protocol (algorithm A); Procedure: Leuven Strict glycemic control protocol (Algorithm B); Procedure: Conventional Intermittent Insulin Protocol (Algorithm C)

• Registration Number: NCT00410852
• Lead Sponsor: Hospital Israelita Albert Einstein

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 of hypoglycemia.

We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose levels between 100mg/dl and 130 mg/dl. This trial evaluates the efficacy and safety of this protocol (algorithm A), compared to a standard endovenous insulin infusion protocol (algorithm B) and a conventional subcutaneous insulin protocol (algorithm C).

Methods : MICU patients with at least one blood glucose ≥ 150 mg/dL and who are on mechanical ventilation, or had SIRS, or are admitted because of trauma or burn will be randomized to one of the following treatments: algorithm A - continuous insulin infusion with adjustments guided by hand held device or desktop software targeting glucose levels between 100mg/dL-130mg/dL; algorithm B - continuous insulin aiming glucose levels between 80mg/dl-110mg/dl using Van den Berghe's insulin protocol; algorithm C - conventional treatment - intermittent subcutaneous administration of insulin if blood glucose levels exceeds 150mg/dL; insulin will be administered as IV boluses in hypotensive patients.

The randomization list was generated in blocks of six by computer software. Patients will be randomly assigned in a 1:1:1 ratio to have their glucose controlled by one of the three insulin algorithms with the use of a central, computerized system accessed by Internet, permitting concealment of allocation list. Randomization will be stratified according to study site.

The study is planned to enroll 165 patients in order to have 80% power to detect a 20mg/dl difference in blood glucose means between groups, assuming standard deviation equal to 33 mg/dl and two-tailed alpha equal to 0.05. Efficacy will be measured by the mean of patients' median blood glucose and safety measured by the incidence of hypoglycemia (≤40 mg/dL). Analysis will follow the intention-to-treat principle.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Study Completion: 2007-03
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Computer-assisted IV insulin infusion protocol (algorithm A)	-
B	Leuven Strict glycemic control protocol (Algorithm B)	-
C	Conventional Intermittent Insulin Protocol (Algorithm C)	-

Primary Outcome Measures

Name	Time	Method
Safety: incidence of hypoglycemia (≤40 mg/dL)during ICU stay	ICU stay
Efficacy: mean of patients' median blood glucose during ICU stay	ICU Stay

Secondary Outcome Measures

Name	Time	Method
Necessity of red blood cell transfusions
Days on inotropic of vasopressor support
Five-day variation in SOFA score	Five days
Days on mechanical ventilation
Days on antibiotics
Death from any cause	ICU and in-hospital
Initiation of dialysis
Platelets through
ICU and hospital length of stay	ICU and in-hospital
90-day health status	90 days
Bilirubin peak

Trial Locations

Locations (5)

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, Brazil