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

NCT00410852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2007-11-02

No results posted yet for this study

Summary

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

Conditions

  • Intensive Care

Interventions

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.

PROCEDURE

Leuven Strict glycemic control protocol (Algorithm B)

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

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.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Alexandre B Cavalcanti, MD · Hospital Israelita Albert Einstein

  • Eliezer Silva, PhD · Hospital Israelita Albert Einstein

  • Jose Eluf-Neto, PhD · Departamento de Medicina Preventiva, Faculdade de Medicina da Universidade de Sao Paulo

  • Milton Caldeira, MD · Hospital Regional Sao Jose

  • Glauco Westphal, MD · Centro Hospitalar UNIMED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Completion
2007-03-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00410852 on ClinicalTrials.gov