Status:

TERMINATED

Cognitive Outcome After Two-stage Liver-Operation

Lead Sponsor:

Charite University, Berlin, Germany

Conditions:

Delirium and Post-operative Cognitive Dysfunction (POCD)

Eligibility:

All Genders

18+ years

Brief Summary

Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.

Eligibility Criteria

Inclusion

  • Study Group:
  • 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

  • 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 acoustical 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
  • Control Group:
  • Inclusion criteria:
  • •Male and female ASA II/III patients, aged ≥ 18 years

Key Trial Info

Start Date :

March 11 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 10 2017

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT01809782

Start Date

March 11 2013

End Date

August 10 2017

Last Update

January 17 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum

Berlin, Germany, 13353