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Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

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ClinicalTrials.gov Identifier: NCT00662922
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : January 11, 2010
Sponsor:
Information provided by:
University Hospital Muenster

Tracking Information
First Submitted Date April 16, 2008
First Posted Date April 21, 2008
Last Update Posted Date January 11, 2010
Study Start Date April 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2008)		 neurocognitive function [ Time Frame: 1 year after ICU discharge ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2008)		 neurocognitive function [ Time Frame: 2,3, and 4 years after ICU discharge ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients
Official Title Does Hypoglycemia Under Intensive Insulin Therapy During Critical Illness Lead to Neurocognitive Dysfunction
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients who were admitted to the hospital ICU after 2003 are screened for hypoglycemia
Condition Critical Illness
Intervention Not Provided
Study Groups/Cohorts
  • 1
    patients with hypoglycemia during intensive care
  • 2
    patients without hypoglycemia during intensive care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 10, 2008)		 74
Original Estimated Enrollment
 (submitted: April 17, 2008)		 100
Actual Study Completion Date September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00662922
Other Study ID Numbers 05-AnIt-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Principle investigator, Dr. Björn Ellger, Department of Anesthesiology and Intensive Care Medicine
Original Responsible Party Same as current
Current Study Sponsor University Hospital Muenster
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Björn Ellger, MD Department of Anesthesiology and Intensive Care Medicine, University Hospital Muenster
PRS Account University Hospital Muenster
Verification Date January 2010