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Tight Glycemic Control in Critical Care Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00096421
First Posted: November 10, 2004
Last Update Posted: October 26, 2006
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:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by:
Hospital Pablo Tobón Uribe
  Purpose
The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Condition Intervention Phase
Critical Illness Hyperglycemia Insulin Resistance Behavioral: Tight control of blood glucose levels Behavioral: Conventional control of glucose levels Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

Further study details as provided by Hospital Pablo Tobón Uribe:

Primary Outcome Measures:
  • Mortality in the next 28 days

Secondary Outcome Measures:
  • Mortality during intensive care
  • Mortality overall in-hospital
  • Mortality among patients who remained in the intensive care unit for more than five days
  • Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
  • Length of stay in the unit
  • Days of ventilatory support
  • Acute renal failure requiring dialysis or hemofiltration
  • The median number of red-cell transfusions
  • SOFA score
  • Critical-illness polyneuropathy

Estimated Enrollment: 504
Study Start Date: July 2003
Estimated Study Completion Date: September 2006
Detailed Description:

Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.

Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 15 years of age or older,
  • Probability of staying in critical care for more than 48 hours,
  • Agreement with the informed consent.

Exclusion Criteria:

  • Pregnancy,
  • Participating in other trials,
  • Diabetic keto-acidosis or diabetic hyperosmolar state,
  • Moribund
  • Do-not-resuscitate orders,
  • Reentry to the critical care unit of the same patient.
  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): NCT00096421


Locations
Colombia
Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Hospital Pablo Tobón Uribe
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Investigators
Principal Investigator: Gisela D De La Rosa, MD Hospital Pablo Tobon Uribe
  More Information

ClinicalTrials.gov Identifier: NCT00096421     History of Changes
Other Study ID Numbers: 4374-04-13031
094-2003.
First Submitted: November 9, 2004
First Posted: November 10, 2004
Last Update Posted: October 26, 2006
Last Verified: October 2006

Keywords provided by Hospital Pablo Tobón Uribe:
Critical illness
Critical care
Hyperglycemia
Intensive care
Intensive Care Units
Insulin resistance
Intensive insulin therapy
Conventional insulin therapy

Additional relevant MeSH terms:
Insulin Resistance
Hyperglycemia
Critical Illness
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes