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Tight Glycemic Control in Critical Care Patients

NCT ID: NCT00096421

Last Updated: 2006-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Critical Illness Hyperglycemia Insulin Resistance

Keywords

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Critical illness Critical care Hyperglycemia Intensive care Intensive Care Units Insulin resistance Intensive insulin therapy Conventional insulin therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tight control of blood glucose levels

Intervention Type BEHAVIORAL

Conventional control of glucose levels

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role collaborator

Hospital Pablo Tobón Uribe

OTHER

Sponsor Role lead

Principal Investigators

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Gisela D De La Rosa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Pablo Tobon Uribe

Locations

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Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Other Identifiers

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094-2003.

Identifier Type: -

Identifier Source: secondary_id

4374-04-13031

Identifier Type: -

Identifier Source: org_study_id