Cognitive Outcome After Two-stage Liver-Operation

Terminated

• Conditions: Delirium and Post-operative Cognitive Dysfunction (POCD)

• Registration Number: NCT01809782
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-26
• Study Start: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2017-04-16
• Study Completion: 2017-08-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
GCS	At postoperative day 7 after second liver operation	Glasgow Coma Scale (GCS)
Simplifies Acute Physiology Score (SAPS II)	At postoperative day 7 after second liver operation	Simplifies Acute Physiology Score (SAPS II)
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)
Sequental Organ Failure Assessment (SOFA)	At postoperative day 7 after second liver operation	Sequental Organ Failure Assessment (SOFA)
TISS	At postoperative day 7 after second liver operation	Therapeutic Interventions Scoring System (TISS)
RASS	At postoperative day 7 after second liver operation	Richmonds Agitation Sedations Scale (RASS)
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)
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
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)
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)
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)
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
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 Cornell Depression Scale (CDS)	Change from pre-operative (Baseline) up to 365 days after surgery	Cornell Depression Scale (CDS)
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 Geriatric Depression Scale (GDS)	Change from pre-operative (Baseline) up to 365 days after surgery	Geriatric Depression Scale (GDS)
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 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)

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany