Tight Glycemic Control in Critical Care Patients | NCT00096421

Studies
Tight Glycemic Control in Critical Care Patients

NCT00096421

Sponsor

Hospital Pablo Tobón Uribe

Status

Completed

Last Update Posted

Oct 26, 2006Estimated

Enrollment

504

Phase

Phase 3

Conditions

Critical Illness
Hyperglycemia
Insulin Resistance

Interventions

Tight control of blood glucose levels
Conventional control of glucose levels

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
094-2003.

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Nov 9, 2004

First Submission Date that Met QC Criteria

Nov 9, 2004

First Posted Date

Nov 10, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2006

Last Update Posted Date

Oct 26, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital Pablo Tobón UribeOTHER

Collaborators

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

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

504

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality in the next 28 days

Secondary Outcomes

Measure	Description	Time Frame
Mortality during intensive care
Mortality overall in-hospital
Mortality among patients who remained in the intensive care unit for more than five days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gisela D De La Rosa, MD	Hospital Pablo Tobon Uribe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Pablo Tobon Uribe		Medellín	Antioquia		Colombia

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D006943	Hyperglycemia
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tight control of blood glucose levels	Behavioral
Conventional control of glucose levels	Behavioral