Cognitive Outcome After Two-stage Liver-Operation

NCT01809782 | Terminated

• 1 other identifier: Two-stage liver
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• POCD

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

  At postoperative day 7 after second liver operation

• Delirium

  Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

  At postoperative day 7 after second liver operation

Secondary Outcomes (22)

• Delirium

  At postoperative day 7 after second liver operation

• Change of POCD

  Change from pre-operative (Baseline) up to 365 days after surgery

• Simplifies Acute Physiology Score (SAPS II)

  At postoperative day 7 after second liver operation

• Length of post-operative hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• Length of post-operative intensive care unit stay

  Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

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)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult female and male patients undergoing two stage liver-operations

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Claudia Spies, MD Prof.

  Charite University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - Universitätsmedizin Berlin, Germany

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 13, 2013
• Study Start: March 11, 2013
• Primary Completion: April 16, 2017
• Study Completion: August 10, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

DE (1)