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:

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 ]

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

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, Learn About Clinical Studies.


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:

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
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

To Top