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Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662922
First Posted: April 21, 2008
Last Update Posted: January 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Muenster
  Purpose
Hypoglycemia occurs frequently during intensive blood glucose control in critically ill patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment, e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment. Therefore we investigate neurocognitive function in patients who had hypoglycemias during their intensive care stay and compare the results to patients without hypoglycaemia whose medical conditions are matched to the hypoglycaemia patients.

Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Does Hypoglycemia Under Intensive Insulin Therapy During Critical Illness Lead to Neurocognitive Dysfunction

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • neurocognitive function [ Time Frame: 1 year after ICU discharge ]

Secondary Outcome Measures:
  • neurocognitive function [ Time Frame: 2,3, and 4 years after ICU discharge ]

Enrollment: 74
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
patients with hypoglycemia during intensive care
2
patients without hypoglycemia during intensive care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who were admitted to the hospital ICU after 2003 are screened for hypoglycemia
Criteria

Inclusion Criteria:

  • all patients

Exclusion Criteria:

  • clinical diagnosis of diabetes mellitus
  • brain injury of any kind prior to or upon ICU-admission
  • pre-existing mental or psychiatric disorder
  • terminal kidney or liver failure prior admission
  • drug abuse,
  • CPR > 5 min
  • HIV
  • Lues
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662922


Locations
Germany
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Björn Ellger, MD Department of Anesthesiology and Intensive Care Medicine, University Hospital Muenster
  More Information

Publications:
Responsible Party: Principle investigator, Dr. Björn Ellger, Department of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00662922     History of Changes
Other Study ID Numbers: 05-AnIt-07
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: January 11, 2010
Last Verified: January 2010

Keywords provided by University Hospital Muenster:
critical illness
hypoglycemia
neurocognitive dysfunction
intensive insulin therapy

Additional relevant MeSH terms:
Hypoglycemia
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes