Not Signed In -
Critical Care |
Assisted Breathing; Intensive Care; Life Support; Tracheostomy; Ventilators |
Clinical Trial: Tight Glycemic Control in Critical Care Patients
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Critical Illness Hyperglycemia Insulin Resistance | Behavior: Tight control of blood glucose levels Behavior: Conventional control of glucose levels | Phase III |
MedlinePlus related topics: Metabolic Disorders; Metabolic Syndrome X
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title: Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
Secondary Outcomes: 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
Expected Total Enrollment: 504
Study start: July 2003; Expected completion: December 2006
Last follow-up: September 2006; Data entry closure: November 2006
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.
Eligibility
Ages Eligible for Study: 15 Years and above, Genders Eligible for Study: Both
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.
Location and Contact Information
Colombia, Antioquia
Hospital Pablo Tobon Uribe, Medellin, Antioquia, Colombia; Recruiting
Jorge H Donado, MD 57-4-4415252 Ext. 859 jdonado@epm.net.co
Gisela D De La Rosa, MD, Principal Investigator
Jorge H Donado, MD, Sub-Investigator
Alvaro H Restrepo, MD, Sub-Investigator
Luis G Gonzalez, MD, Sub-Investigator
Carlos A Cadavid, MD, Sub-Investigator
Alvaro M Quintero, MD, Sub-Investigator
Juan M Toro, MD, Sub-Investigator
Clara M Arango, MD, Sub-Investigator
Marisol Bedoya, RN, Sub-Investigator
Nora E Saldarriaga, MD, Sub-Investigator
Juan C Valencia, MD, Sub-Investigator
Jorge B Velasquez, MD, Sub-Investigator
Pablo E Aleman, MD, Sub-Investigator
Juan C Chavarriaga, MD, Sub-Investigator
Andres Yepes, MD, Sub-Investigator
Jose W Pulido, MD, Sub-Investigator
Gisela D De La Rosa, MD, Principal Investigator, Hospital Pablo Tobon Uribe
More Information
Record last reviewed: November 2004
Last Updated: November 15, 2004
Record first received: November 9, 2004
ClinicalTrials.gov Identifier: NCT00096421
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Caring for a Child Dependent on Medical Technology (Nemours Foundation)
- ClinicalTrials.gov: Ventilators, Mechanical (National Institutes of Health)
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