NCT00096421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

November 9, 2004

Last Update Submit

October 24, 2006

Conditions

Critical IllnessHyperglycemiaInsulin Resistance

Keywords

Critical illnessCritical careHyperglycemiaIntensive careIntensive Care UnitsInsulin resistanceIntensive insulin therapyConventional insulin therapy

Outcome Measures

Primary Outcomes (1)

  • Mortality in the next 28 days

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Interventions

Tight control of blood glucose levelsBEHAVIORAL
Conventional control of glucose levelsBEHAVIORAL

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • Probability of staying in critical care for more than 48 hours,
  • Agreement with the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Critical IllnessHyperglycemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinism

Study Officials

  • Gisela D De La Rosa, MD

    Hospital Pablo Tobon Uribe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 10, 2004

Study Start

July 1, 2003

Study Completion

September 1, 2006

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

CO(1)