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Clinical Trials/NCT00662922
NCT00662922CompletedNot Applicable

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

University Hospital Muenster1 site in 1 country74 target enrollmentStarted: April 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
neurocognitive function

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

neurocognitive function

Time Frame: 1 year after ICU discharge

Secondary Outcomes

  • neurocognitive function(2,3, and 4 years after ICU discharge)

Investigators

Sponsor
University Hospital Muenster
Sponsor Class
Other

Study Sites (1)

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