KULeuven Intensive Insulin Therapy Study in Medical Inten... | NCT00115479

Studies
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

NCT00115479

Sponsor

KU Leuven

Status

Completed

Last Update Posted

May 4, 2006Estimated

Enrollment

1,200

Phase

Phase 2

Conditions

Critical Illness

Interventions

intensive insulin therapy to maintain normoglycemia

Countries

Belgium

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

Status Module

Record Verification Date

Jun 2005

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

Mar 2002

Primary Completion Date

Not provided

Completion Date

Jun 2005

First Submitted Date

Jun 22, 2005

First Submission Date that Met QC Criteria

Jun 22, 2005

First Posted Date

Jun 23, 2005Estimated

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

May 3, 2006

Last Update Posted Date

May 4, 2006Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

KU LeuvenOTHER

Collaborators

Name	Class
Fund for Scientific Research, Flanders, Belgium	OTHER
Novo Nordisk A/S	INDUSTRY

Description Module

Brief Summary

In a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. Whether this intervention also improves prognosis of medical intensive care patients remains unknown. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. On admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Detailed Description

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200

Name	Type	Description	Arm Group Labels	Other Names
intensive insulin therapy to maintain normoglycemia	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality

Secondary Outcomes

Measure	Description	Time Frame
mechanical ventilatory support-dependency
stay in Intensive Care Unit (ICU)
stay in hospital

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults admitted to ICU and anticipated to require intensive care for at least a few days

Exclusion Criteria:

Expected short ICU stay
Therapy restricted upon admission
Surgical ICU patients
Other studies
Below 18 years
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Greet H Van den Berghe, MD, PhD	K.U.Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic University of Leuven, University Hospital Gasthuisberg		Leuven		B-3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11794168	Background	van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
16452557	Result	Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med. 2006 Feb 2;354(5):449-61. doi: 10.1056/NEJMoa052521.

ID	Term
D016638	Critical Illness
D007333	Insulin Resistance

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D006946	Hyperinsulinism

ID	Type	Description	Link
FWO grant number G.0278.03
KULeuven OT/03/56