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

November 9, 2004
October 24, 2006
July 2003
Not Provided
Mortality in the next 28 days
Same as current
Complete list of historical versions of study NCT00096421 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Tight Glycemic Control in Critical Care Patients
Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Critical Illness
  • Hyperglycemia
  • Insulin Resistance
  • Behavioral: Tight control of blood glucose levels
  • Behavioral: Conventional control of glucose levels
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
504
September 2006
Not Provided

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.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT00096421
4374-04-13031, 094-2003.
Not Provided
Not Provided
Hospital Pablo Tobón Uribe
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Principal Investigator: Gisela D De La Rosa, MD Hospital Pablo Tobon Uribe
Hospital Pablo Tobón Uribe
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP