Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

NCT00662922 | Completed

• 1 other identifier: 05-AnIt-07
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

critical illness; hypoglycemia; neurocognitive dysfunction; intensive insulin therapy

Outcome Measures

Primary Outcomes (1)

• neurocognitive function

  1 year after ICU discharge

Secondary Outcomes (1)

• neurocognitive function

  2,3, and 4 years after ICU discharge

Study Arms (2)

1

patients with hypoglycemia during intensive care

2

patients without hypoglycemia during intensive care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who were admitted to the hospital ICU after 2003 are screened for hypoglycemia

You may qualify if:

• all patients

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care, University Hospital Münster

Münster, D-48149, Germany

Location

Related Publications (1)

• 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.

  PMID: 20032274 RESULT

MeSH Terms

Conditions

Critical Illness; Hypoglycemia; Cognition Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Björn Ellger, MD

  Department of Anesthesiology and Intensive Care Medicine, University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 11, 2010

Record last verified: 2010-01

Locations

DE (1)