Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

Critical Illness Clinical Trial

Official title:

Does Hypoglycemia Under Intensive Insulin Therapy During Critical Illness Lead to Neurocognitive Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662922
• Other study ID #: 05-AnIt-07
• Status: Completed
• Phase: N/A
• First received: April 16, 2008
• Last updated: January 8, 2010
• Start date: April 2008
• Est. completion date: September 2008

Study information

• Verified date: January 2010
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Critical Illness
• Hypoglycemia

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care, University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurocognitive function		1 year after ICU discharge	No
Secondary	neurocognitive function		2,3, and 4 years after ICU discharge	No