Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients - Full Text View

Sponsored by:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00662922

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:	Case Control, 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

Drug Information available for: Insulin

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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

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

No publications provided

Responsible Party:	Department of Anesthesiology and Intensive Care Medicine ( Principle investigator, Dr. Björn Ellger )
Study ID Numbers:	05-AnIt-07
Study First Received:	April 16, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00662922 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Muenster:

critical illness
hypoglycemia
neurocognitive dysfunction
intensive insulin therapy

Study placed in the following topic categories:

Metabolic Diseases
Critical Illness
Glucose Metabolism Disorders

Hypoglycemia
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Disease Attributes
Metabolic Diseases
Pathologic Processes

Critical Illness
Glucose Metabolism Disorders
Hypoglycemia

ClinicalTrials.gov processed this record on September 10, 2009