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Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

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ClinicalTrials.gov Identifier: NCT00662922
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
University Hospital Muenster

Study Description
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Brief Summary:
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 or disease
Critical Illness

Study Design
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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Does Hypoglycemia Under Intensive Insulin Therapy During Critical Illness Lead to Neurocognitive Dysfunction
Study Start Date : April 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Groups and Cohorts
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Group/Cohort
1
patients with hypoglycemia during intensive care
2
patients without hypoglycemia during intensive care


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Germany
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Björn Ellger, MD Department of Anesthesiology and Intensive Care Medicine, University Hospital Muenster
More Information
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Publications of Results:

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Responsible Party: Principle investigator, Dr. Björn Ellger, Department of Anesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT00662922    
Other Study ID Numbers: 05-AnIt-07
First Posted: April 21, 2008    Key Record Dates
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:
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Hypoglycemia
Critical Illness
Glucose Metabolism Disorders
 Metabolic Diseases
Disease Attributes
Pathologic Processes