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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1
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum
Berlin, Germany, 13353