Cognitive Outcome After Two-stage Liver-Operation

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

Official Title
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Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy

Conditions
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Delirium and Post-operative Cognitive Dysfunction (POCD)

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group:20 patients undergoing two stage liver-operation<br>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)<br>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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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