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: Diabetes Medicines 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
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:

Duning T, van den Heuvel I, Dickmann A, Volkert T, Wempe C, Reinholz J, Lohmann H, Freise H, Ellger B. Hypoglycemia aggravates critical illness-induced neurocognitive dysfunction. Diabetes Care. 2010 Mar;33(3):639-44. doi: 10.2337/dc09-1740. Epub 2009 Dec 23.


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:


Critical Illness Hypoglycemia Disease Attributes	Glucose Metabolism Disorders Metabolic Diseases Pathologic Processes

ClinicalTrials.gov processed this record on February 27, 2015

To Top