Cognitive Outcome After Two-stage Liver-Operation

N/ATerminatedNCT01809782

Charite University, Berlin, Germany23 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Delirium and Post-operative Cognitive Dysfunction (POCD)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Berlin, Germany

Outcomes

Primary Outcomes

POCD

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

Time frame: At postoperative day 7 after second liver operation

Delirium

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

Time frame: At postoperative day 7 after second liver operation

Secondary Outcomes

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)

Time frame: 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

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

Simplifies Acute Physiology Score (SAPS II)

Time frame: At postoperative day 7 after second liver operation

Length of post-operative hospital stay

Post-anaesthesia Discharge Scoring Stay (PADSS)

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

Length of post-operative intensive care unit stay

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Criteria of internal standard operating procedures (SOP)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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)

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

Mortality

postoperative survival

Time frame: after 90 days, after 182 days and after 365 days

Acute Physiological and Chronic Health Evaluation (Apache II)

Time frame: At postoperative day 7 after second liver operation

Sequental Organ Failure Assessment (SOFA)

Time frame: At postoperative day 7 after second liver operation

TISS

Therapeutic Interventions Scoring System (TISS)

Time frame: At postoperative day 7 after second liver operation

RASS

Richmonds Agitation Sedations Scale (RASS)

Time frame: At postoperative day 7 after second liver operation

GCS

Glasgow Coma Scale (GCS)

Time frame: 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))

Time frame: At postoperative day 7 after second liver operation

Change of EuroQoL instrument (EQ-5D)

EuroQoL instrument (EQ-5D)

Time frame: 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)

Time frame: 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)

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

Change of Geriatric Depression Scale (GDS)

Geriatric Depression Scale (GDS)

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

Change of Cornell Depression Scale (CDS)

Cornell Depression Scale (CDS)

Time frame: 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)

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