Cognitive Outcome After Two-stage Liver-Operation

NCT ID: NCT01809782

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-11
• Study Completion Date: 2017-08-10

Brief Summary

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

Conditions

Delirium and Post-operative Cognitive Dysfunction (POCD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Study group:20 patients undergoing two stage liver-operation

Patients undergo two liver operations.First surgery: insitu-split for induction of proliferation in the remaining liver tissue; Second surgery: resection of the liver Tumor (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year)

No interventions assigned to this group

Control group: 20 patients (ASA class II/III)

Relatives from study personel or patients from outpatient clinics from Charité in Berlin and surrounding area (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year)

No interventions assigned to this group

Eligibility Criteria

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

•Male and female ASA II/III patients, aged ≥ 18 years

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 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:

• Mini-Mental-State-Examination ≤ 23 Points
• Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
• Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin, Germany

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

Two-stage liver

Identifier Type: -

Identifier Source: org_study_id