Tight Glycemic Control in Critical Care Patients

October 24, 2006 updated by: Hospital Pablo Tobón Uribe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

504

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Hospital Pablo Tobon Uribe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality in the next 28 days

Secondary Outcome Measures

Outcome Measure
SOFA score
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
Critical-illness polyneuropathy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pablo Tobón Uribe

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 9, 2004

First Posted (Estimate)

November 10, 2004

Study Record Updates

Last Update Posted (Estimate)

October 26, 2006

Last Update Submitted That Met QC Criteria

October 24, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4374-04-13031
  • 094-2003.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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