Tight Glycemic Control in Critical Care Patients

This study has been completed.
Sponsor:
Collaborator:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Information provided by:
Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier:
NCT00096421
First received: November 9, 2004
Last updated: October 24, 2006
Last verified: October 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

Resource links provided by NLM:


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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00096421     History of Changes
Other Study ID Numbers: 4374-04-13031, 094-2003.
Study First Received: November 9, 2004
Last Updated: October 24, 2006
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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

ClinicalTrials.gov processed this record on July 22, 2014