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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
intensive insulin therapy to maintain normoglycemia
Sponsored by
KU Leuven
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring critical illness, intensive care, outcome, insulin, blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catholic University of Leuven, University Hospital Gasthuisberg

Outcomes

Primary Outcome Measures

mortality

Secondary Outcome Measures

mechanical ventilatory support-dependency
stay in Intensive Care Unit (ICU)
stay in hospital
organ failure
morbidity
a long-term follow up is planned to take place 6 and 12 months after hospital discharge

Full Information

First Posted
June 22, 2005
Last Updated
May 3, 2006
Sponsor
KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00115479
Brief Title
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Official Title
KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
KU Leuven
Collaborators
Fund for Scientific Research, Flanders, Belgium, Novo Nordisk A/S

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
critical illness, intensive care, outcome, insulin, blood glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intensive insulin therapy to maintain normoglycemia
Primary Outcome Measure Information:
Title
mortality
Secondary Outcome Measure Information:
Title
mechanical ventilatory support-dependency
Title
stay in Intensive Care Unit (ICU)
Title
stay in hospital
Title
organ failure
Title
morbidity
Title
a long-term follow up is planned to take place 6 and 12 months after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greet H Van den Berghe, MD, PhD
Organizational Affiliation
K.U.Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Leuven, University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
11794168
Citation
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.
Results Reference
background
PubMed Identifier
16452557
Citation
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.
Results Reference
result
PubMed Identifier
23506003
Citation
Boonen E, Vervenne H, Meersseman P, Andrew R, Mortier L, Declercq PE, Vanwijngaerden YM, Spriet I, Wouters PJ, Vander Perre S, Langouche L, Vanhorebeek I, Walker BR, Van den Berghe G. Reduced cortisol metabolism during critical illness. N Engl J Med. 2013 Apr 18;368(16):1477-88. doi: 10.1056/NEJMoa1214969. Epub 2013 Mar 19.
Results Reference
derived
PubMed Identifier
19589139
Citation
Langouche L, Vander Perre S, Frystyk J, Flyvbjerg A, Hansen TK, Van den Berghe G. Adiponectin, retinol-binding protein 4, and leptin in protracted critical illness of pulmonary origin. Crit Care. 2009;13(4):R112. doi: 10.1186/cc7956. Epub 2009 Jul 9.
Results Reference
derived

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KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

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