Cognitive Outcome After Two-stage Liver-Operation

Overview

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

Full Title of Study: “Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation – a Pilotstudy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 16, 2017

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • POCD
    • Time Frame: At postoperative day 7 after second liver operation
    • Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB); calculated in relation to a healthy control group without intervention
  • Delirium
    • Time Frame: At postoperative day 7 after second liver operation
    • Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

Secondary Measures

  • Delirium
    • Time Frame: At postoperative day 7 after second liver operation
    • Measured by Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and Confusion Assessment Method (CAM) and Intensive Care Delirium Screening Checklist (ICDSC) and Delirium Detection Scale (DDS) and Delirium Rating Scale (DRS) and The Nursing Delirium Screening Scale (NU-DESC)
  • Change of POCD
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB) calculated in relation to a healthy control group without intervention
  • Simplifies Acute Physiology Score (SAPS II)
    • Time Frame: At postoperative day 7 after second liver operation
    • Simplifies Acute Physiology Score (SAPS II)
  • Length of post-operative hospital stay
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    • Post-anaesthesia Discharge Scoring Stay (PADSS)
  • Length of post-operative intensive care unit stay
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
    • Criteria of internal standard operating procedures (SOP)
  • Pain
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    • Measured by Numeric Rating Scale (NRS) or Verbal Rating Scale (VRS) or Visual Analogue Scale (VAS) or Behavioural Pain Scale (BPS)
  • The rate of post-operative organ dysfunctions and complications
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    • Cerebral-, cardiovascular-, cardiac- pulmonary-, gastrointestinal- and renal dysfunctions
  • Incidence of systemic inflammatory response syndrome (SIRS) and infection
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
    • Centers for Disease Control (CDC) and American Thoracic Society (ATS) criteria
  • Change of 36-item short form health survey (SF-36)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • 36-item short form health survey (SF-36)
  • Mortality
    • Time Frame: after 90 days, after 182 days and after 365 days
    • postoperative survival
  • Acute Physiological and Chronic Health Evaluation (Apache II)
    • Time Frame: At postoperative day 7 after second liver operation
    • Acute Physiological and Chronic Health Evaluation (Apache II)
  • Sequental Organ Failure Assessment (SOFA)
    • Time Frame: At postoperative day 7 after second liver operation
    • Sequental Organ Failure Assessment (SOFA)
  • TISS
    • Time Frame: At postoperative day 7 after second liver operation
    • Therapeutic Interventions Scoring System (TISS)
  • RASS
    • Time Frame: At postoperative day 7 after second liver operation
    • Richmonds Agitation Sedations Scale (RASS)
  • GCS
    • Time Frame: At postoperative day 7 after second liver operation
    • Glasgow Coma Scale (GCS)
  • RIFLE criteria
    • Time Frame: At postoperative day 7 after second liver operation
    • Risk Injury Failure Loss End Stage Kidney Disease (RIFLE = risk (R), injury (I), and failure (F), sustained loss (L) and end-stage kidney disease (E))
  • Change of EuroQoL instrument (EQ-5D)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • EuroQoL instrument (EQ-5D)
  • Change of Barthel Index(for Activities of Daily Living, ADL)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Barthel Index (for Activities of Daily Living, ADL)
  • Change of Instrumentelle Aktivität im täglichen Leben (IATL)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Instrumentelle Aktivität im täglichen Leben (IATL)
  • Change of Geriatric Depression Scale (GDS)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Geriatric Depression Scale (GDS)
  • Change of Cornell Depression Scale (CDS)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Cornell Depression Scale (CDS)
  • Change of Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
    • Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
    • Hospital Anxiety and Depression Scale deutsche Version (HADS-D)

Participating in This Clinical Trial

Study Group: 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 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité – Universitätsmedizin Berlin, Germany – Charite University, Berlin, Germany
  • Overall Official(s)
    • Claudia Spies, MD Prof., Study Director, Charite University, Berlin, Germany

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