Skip to main content
OpenTrials
Completed

NCT Number: NCT00096421

Tight Glycemic Control in Critical Care Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tight control of blood glucose levels

Behavioral

Conventional control of glucose levels

Behavioral

Primary outcomes

  1. Mortality in the next 28 days

Secondary outcomes

  1. Mortality during intensive care

  2. Mortality overall in-hospital

  3. Mortality among patients who remained in the intensive care unit for more than five days

  4. Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection

  5. Length of stay in the unit

  6. Days of ventilatory support

  7. Acute renal failure requiring dialysis or hemofiltration

  8. The median number of red-cell transfusions

  9. SOFA score

  10. Critical-illness polyneuropathy

Sponsors and collaborators

Lead sponsor

Hospital Pablo Tobón Uribe

Other

Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Registry information

Official study title

Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study

Important dates

Study start
2003
Study completion
2006
First posted
Nov 10, 2004
Registry last updated
Oct 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.