Tight Glycemic Control in Critical Care Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096421
• Other study ID #: 4374-04-13031
• Secondary ID: 094-2003.
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2004
• Last updated: October 24, 2006
• Start date: July 2003
• Est. completion date: September 2006

Study information

• Verified date: October 2006
• Source: Hospital Pablo Tobón Uribe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Hyperglycemia
• Insulin Resistance

Intervention

Behavioral:
• Tight control of blood glucose levels

• Conventional control of glucose levels

Locations

Country	Name	City	State
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Pablo Tobón Uribe	Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in the next 28 days
Secondary	Mortality during intensive care
Secondary	Mortality overall in-hospital
Secondary	Mortality among patients who remained in the intensive care unit for more than five days
Secondary	Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
Secondary	Length of stay in the unit
Secondary	Days of ventilatory support
Secondary	Acute renal failure requiring dialysis or hemofiltration
Secondary	The median number of red-cell transfusions
Secondary	SOFA score
Secondary	Critical-illness polyneuropathy