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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410852
First Posted: December 13, 2006
Last Update Posted: November 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Hospital Israelita Albert Einstein
  Purpose
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • Efficacy: mean of patients' median blood glucose during ICU stay [ Time Frame: ICU Stay ]
  • Safety: incidence of hypoglycemia (≤40 mg/dL)during ICU stay [ Time Frame: ICU stay ]

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

Enrollment: 168
Study Start Date: May 2005
Study Completion Date: March 2007
Arms Assigned Interventions
Experimental: A Procedure: Computer-assisted IV insulin infusion protocol (algorithm A)
Computer assisted insulin protocol (CAIP), with continuous intravenous insulin adjustments aiming blood glucose levels between 100 mg/dl and 130 mg/dl.
Experimental: B Procedure: Leuven Strict glycemic control protocol (Algorithm B)
Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.
Active Comparator: C Procedure: Conventional Intermittent Insulin Protocol (Algorithm C)
Conventional treatment: intermitent subcutaneous insulin according to a sliding scale, starting with blood glucose levels higher than 150mg/dl.

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.

  Eligibility

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410852


Locations
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, Brazil, 05651-901
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Chair: Alexandre B Cavalcanti, MD Hospital Israelita Albert Einstein
Study Director: 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
Principal Investigator: Milton Caldeira, MD Hospital Regional Sao Jose
Principal Investigator: Glauco Westphal, MD Centro Hospitalar UNIMED
  More Information

ClinicalTrials.gov Identifier: NCT00410852     History of Changes
Other Study ID Numbers: FAPESP 2005/50557-5
First Submitted: December 12, 2006
First Posted: December 13, 2006
Last Update Posted: November 2, 2007
Last Verified: October 2007

Keywords provided by Hospital Israelita Albert Einstein:
Insulin
Hyperglycemia
Hypoglycemia
Intensive care
Critical care

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs