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

NCT00410852 | Completed

• 1 other identifier: FAPESP 2005/50557-5
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).

Conditions

Intensive Care

Keywords

Insulin; Hyperglycemia; Hypoglycemia; Intensive care; Critical care

Outcome Measures

Primary Outcomes (2)

• Efficacy: mean of patients' median blood glucose during ICU stay

  ICU Stay

• Safety: incidence of hypoglycemia (≤40 mg/dL)during ICU stay

  ICU stay

Secondary Outcomes (11)

• Death from any cause

  ICU and in-hospital

• ICU and hospital length of stay

  ICU and in-hospital

• Five-day variation in SOFA score

  Five days

• 90-day health status

  90 days

• Days on mechanical ventilation

Study Arms (3)

A

EXPERIMENTAL

Procedure: Computer-assisted IV insulin infusion protocol (algorithm A)

B

EXPERIMENTAL

Procedure: Leuven Strict glycemic control protocol (Algorithm B)

C

ACTIVE COMPARATOR

Procedure: Conventional Intermittent Insulin Protocol (Algorithm C)

Interventions

Computer-assisted IV insulin infusion protocol (algorithm A) PROCEDURE

Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl.

A

Leuven Strict glycemic control protocol (Algorithm B) PROCEDURE

Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.

B

Conventional Intermittent Insulin Protocol (Algorithm C) PROCEDURE

Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl.

C

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (5)

Complexo Hospitalar UNIMED

Joinville, Santa Catarina, Brazil

Location

Hospital Dona Helena

Joinville, Santa Catarina, Brazil

Location

Hospital Regional Sao Jose

Joinville, Santa Catarina, Brazil

Location

Hospital Estadual Mario Covas

Santo André, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651-901, Brazil

Location

MeSH Terms

Conditions

Insulin Resistance; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alexandre B Cavalcanti, MD

  Hospital Israelita Albert Einstein

  STUDY CHAIR

• Eliezer Silva, PhD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

• Jose Eluf-Neto, PhD

  Departamento de Medicina Preventiva, Faculdade de Medicina da Universidade de Sao Paulo

  STUDY DIRECTOR

• Milton Caldeira, MD

  Hospital Regional Sao Jose

  PRINCIPAL INVESTIGATOR

• Glauco Westphal, MD

  Centro Hospitalar UNIMED

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Start: May 1, 2005
• Study Completion: March 1, 2007
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

BR (5)