Delirium and Post-operative Cognitive Dysfunction (POCD)
Conditions
Brief summary
Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
Interventions
None listed
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POCD | 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 | At postoperative day 7 after second liver operation | Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simplifies Acute Physiology Score (SAPS II) | At postoperative day 7 after second liver operation | Simplifies Acute Physiology Score (SAPS II) |
| Length of post-operative hospital stay | 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 | Participants will be followed for the duration of hospital stay, an expected average of 3 weeks | Criteria of internal standard operating procedures (SOP) |
| Pain | 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 | 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 | 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) | Change from pre-operative (Baseline) up to 365 days after surgery | 36-item short form health survey (SF-36) |
| Mortality | after 90 days, after 182 days and after 365 days | postoperative survival |
| Acute Physiological and Chronic Health Evaluation (Apache II) | At postoperative day 7 after second liver operation | Acute Physiological and Chronic Health Evaluation (Apache II) |
| Sequental Organ Failure Assessment (SOFA) | At postoperative day 7 after second liver operation | Sequental Organ Failure Assessment (SOFA) |
| Delirium | 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) |
| RASS | At postoperative day 7 after second liver operation | Richmonds Agitation Sedations Scale (RASS) |
| GCS | At postoperative day 7 after second liver operation | Glasgow Coma Scale (GCS) |
| RIFLE criteria | 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) | 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) | 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) | Change from pre-operative (Baseline) up to 365 days after surgery | Instrumentelle Aktivität im täglichen Leben (IATL) |
| Change of Geriatric Depression Scale (GDS) | Change from pre-operative (Baseline) up to 365 days after surgery | Geriatric Depression Scale (GDS) |
| Change of Cornell Depression Scale (CDS) | 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) | Change from pre-operative (Baseline) up to 365 days after surgery | Hospital Anxiety and Depression Scale deutsche Version (HADS-D) |
| TISS | At postoperative day 7 after second liver operation | Therapeutic Interventions Scoring System (TISS) |
| Change of POCD | 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 |
Countries
Germany
Outcome results
None listed