Cognitive Outcome After Two-stage Liver-Operation (2-StaLi)

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult female and male patients undergoing two stage liver-operations

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study group:20 patients undergoing two stage liver-operation; 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); 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?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2013
• Primary Completion (Actual): April 16, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: Two-stage liver