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Sponsors and Collaborators: |
Hospital Israelita Albert Einstein Fundação de Amparo à Pesquisa do Estado de São Paulo |
Information provided by: | Hospital Israelita Albert Einstein |
ClinicalTrials.gov Identifier: | NCT00410852 |
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) |
MedlinePlus related topics: | Hypoglycemia |
ChemIDplus related topics: | Insulin Dextrose |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients |
Enrollment: | 168 |
Study Start Date: | May 2005 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
A: Experimental |
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.
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B: Experimental |
Procedure: Leuven Strict glycemic control protocol (Algorithm B)
Leuven protocol: continuous intravenous insulin infusion aimiming blood glucose levels between 80mg/dl and 110mg/dl.
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C: Active Comparator |
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.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Criteria 1, 2 and 3 must be present:
At least one of the following:
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:
Brazil | |||||
Hospital Israelita Albert Einstein | |||||
Sao Paulo, Brazil, 05651-901 | |||||
Brazil, Santa Catarina | |||||
Hospital Dona Helena | |||||
Joinville, Santa Catarina, Brazil | |||||
Hospital Regional Sao Jose | |||||
Joinville, Santa Catarina, Brazil | |||||
Complexo Hospitalar UNIMED | |||||
Joinville, Santa Catarina, Brazil | |||||
Brazil, Sao Paulo | |||||
Hospital Estadual Mario Covas | |||||
Santo Andre, Sao Paulo, Brazil |
Hospital Israelita Albert Einstein |
Fundação de Amparo à Pesquisa do Estado de São Paulo |
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 |
Study ID Numbers: | FAPESP 2005/50557-5 |
First Received: | December 12, 2006 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00410852 |
Health Authority: | Brazil: National Committee of Ethics in Research |
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