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Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy

18 Years
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Delirium and Post-operative Cognitive Dysfunction (POCD)

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Trial Information

Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy

Inclusion Criteria:

- Patients undergoing a planned elective in situ split liver operation with following
resection after approximately ten days with or without additional elective surgery in
the same session at the University Hospital, Campus Virchow-Klinikum of the Charité -
University Medicine Berlin

- Patients aged greater than or equal to 18 years

- Patients of both genders

- Offered patient information and written informed consent

- No participation in another clinical trial according to the German Drug Law (AMG)
during the trial and one month before inclusion

Exclusion Criteria:

- Lacking willingness to save and hand out pseudonymised data within the clinical study

- Accommodation in an institution due to an official or judicial order

- Staff of Charite University hospital Berlin, Virchow Klinikum

- Illiteracy

- Unability of German language use

- Visual and acustical impairment

- core on the mini mental state examination (MMSE) at screening of 23 or less

- American Society of Anaesthesiologists (ASA) Classification greater than IV

- Ascertained psychiatric disease

- Intake of psychotropic drugs (including sleeping pills and Benzodiazepine)

- Symptomatic bradycardia

- Symptomatic heart rhythm disorder (arrhythmia)

- Coronary heart disease Canadian Society of Anaesthesiologists criteria (CSC) stadium
IV or the presentation of a coronary heart disease that needs intervention

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:


Outcome Description:

Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB); calculated in relation to a healthy control group without intervention

Outcome Time Frame:

At postoperative day 7 after second liver operation

Safety Issue:


Principal Investigator

Claudia Spies, MD Prof.

Investigator Role:

Study Director

Investigator Affiliation:

Charite University, Berlin, Germany


Germany: Ethics Commission

Study ID:

Two-stage liver



Start Date:

March 2013

Completion Date:

February 2015

Related Keywords:

  • Delirium and Post-operative Cognitive Dysfunction (POCD)
  • Delirium
  • Cognition Disorders