Delirium and Post-operative Cognitive Dysfunction (POCD) Clinical Trial
— 2-StaLiOfficial title:
Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy
| Verified date | January 2018 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
| Status | Terminated |
| Enrollment | 23 |
| Est. completion date | August 10, 2017 |
| Est. primary completion date | April 16, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Charite University, Berlin, Germany |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Delirium | Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) | At postoperative day 7 after second liver operation | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Simplifies Acute Physiology Score (SAPS II) | Simplifies Acute Physiology Score (SAPS II) | At postoperative day 7 after second liver operation | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Mortality | postoperative survival | after 90 days, after 182 days and after 365 days | |
| Secondary | Acute Physiological and Chronic Health Evaluation (Apache II) | Acute Physiological and Chronic Health Evaluation (Apache II) | At postoperative day 7 after second liver operation | |
| Secondary | Sequental Organ Failure Assessment (SOFA) | Sequental Organ Failure Assessment (SOFA) | At postoperative day 7 after second liver operation | |
| Secondary | TISS | Therapeutic Interventions Scoring System (TISS) | At postoperative day 7 after second liver operation | |
| Secondary | RASS | Richmonds Agitation Sedations Scale (RASS) | At postoperative day 7 after second liver operation | |
| Secondary | GCS | Glasgow Coma Scale (GCS) | At postoperative day 7 after second liver operation | |
| Secondary | 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 | |
| Secondary | Change of EuroQoL instrument (EQ-5D) | EuroQoL instrument (EQ-5D) | Change from pre-operative (Baseline) up to 365 days after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Change of Geriatric Depression Scale (GDS) | Geriatric Depression Scale (GDS) | Change from pre-operative (Baseline) up to 365 days after surgery | |
| Secondary | Change of Cornell Depression Scale (CDS) | Cornell Depression Scale (CDS) | Change from pre-operative (Baseline) up to 365 days after surgery | |
| Secondary | 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 |