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Completed

NCT Number: NCT00115479

KULeuven Intensive Insulin Therapy Study in Medical Intensive Care Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Catholic University of Leuven, University Hospital Gasthuisberg

Leuven, B-3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive insulin therapy to maintain normoglycemia

Drug

Primary outcomes

  1. mortality

Secondary outcomes

  1. mechanical ventilatory support-dependency

  2. stay in Intensive Care Unit (ICU)

  3. stay in hospital

  4. organ failure

  5. morbidity

  6. a long-term follow up is planned to take place 6 and 12 months after hospital discharge

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium
  • Novo Nordisk A/S

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Jun 23, 2005
Registry last updated
May 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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