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Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

This study has been completed.
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00662922
First received: April 16, 2008
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  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:

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • neurocognitive function [ Time Frame: 1 year after ICU discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neurocognitive function [ Time Frame: 2,3, and 4 years after ICU discharge ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 16, 2008
Last Updated: January 8, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 30, 2016