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Tight Glycemic Control in Critical Care Patients

Primary Purpose

Critical Illness, Hyperglycemia, Insulin Resistance

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Tight control of blood glucose levels
Conventional control of glucose levels
Sponsored by
Hospital Pablo Tobón Uribe
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Pablo Tobon Uribe

Outcomes

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

Full Information

First Posted
November 9, 2004
Last Updated
October 24, 2006
Sponsor
Hospital Pablo Tobón Uribe
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
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1. Study Identification

Unique Protocol Identification Number
NCT00096421
Brief Title
Tight Glycemic Control in Critical Care Patients
Official Title
Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Pablo Tobón Uribe
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Hyperglycemia, Insulin Resistance
Keywords
Critical illness, Critical care, Hyperglycemia, Intensive care, Intensive Care Units, Insulin resistance, Intensive insulin therapy, Conventional insulin therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
504 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Tight control of blood glucose levels
Intervention Type
Behavioral
Intervention Name(s)
Conventional control of glucose levels
Primary Outcome Measure Information:
Title
Mortality in the next 28 days
Secondary Outcome Measure Information:
Title
Mortality during intensive care
Title
Mortality overall in-hospital
Title
Mortality among patients who remained in the intensive care unit for more than five days
Title
Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
Title
Length of stay in the unit
Title
Days of ventilatory support
Title
Acute renal failure requiring dialysis or hemofiltration
Title
The median number of red-cell transfusions
Title
SOFA score
Title
Critical-illness polyneuropathy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisela D De La Rosa, MD
Organizational Affiliation
Hospital Pablo Tobon Uribe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

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Tight Glycemic Control in Critical Care Patients

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