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

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ClinicalTrials.gov Identifier: NCT01809782
Recruitment Status : Terminated
First Posted : March 13, 2013
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Tracking Information
First Submitted Date February 26, 2013
First Posted Date March 13, 2013
Last Update Posted Date January 17, 2018
Actual Study Start Date March 11, 2013
Actual Primary Completion Date April 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2013)
  • POCD [ Time Frame: 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 [ Time Frame: At postoperative day 7 after second liver operation ]
    Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01809782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 7, 2013)
  • Delirium [ Time Frame: 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 [ Time Frame: 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
  • Simplifies Acute Physiology Score (SAPS II) [ Time Frame: At postoperative day 7 after second liver operation ]
    Simplifies Acute Physiology Score (SAPS II)
  • Length of post-operative hospital stay [ Time Frame: 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 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    Criteria of internal standard operating procedures (SOP)
  • Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    36-item short form health survey (SF-36)
  • Mortality [ Time Frame: after 90 days, after 182 days and after 365 days ]
    postoperative survival
  • Acute Physiological and Chronic Health Evaluation (Apache II) [ Time Frame: At postoperative day 7 after second liver operation ]
    Acute Physiological and Chronic Health Evaluation (Apache II)
  • Sequental Organ Failure Assessment (SOFA) [ Time Frame: At postoperative day 7 after second liver operation ]
    Sequental Organ Failure Assessment (SOFA)
  • TISS [ Time Frame: At postoperative day 7 after second liver operation ]
    Therapeutic Interventions Scoring System (TISS)
  • RASS [ Time Frame: At postoperative day 7 after second liver operation ]
    Richmonds Agitation Sedations Scale (RASS)
  • GCS [ Time Frame: At postoperative day 7 after second liver operation ]
    Glasgow Coma Scale (GCS)
  • RIFLE criteria [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Instrumentelle Aktivität im täglichen Leben (IATL)
  • Change of Geriatric Depression Scale (GDS) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Geriatric Depression Scale (GDS)
  • Change of Cornell Depression Scale (CDS) [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
Original Secondary Outcome Measures
 (submitted: March 11, 2013)
  • Delirium [ Time Frame: 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 [ Time Frame: 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
  • Simplifies Acute Physiology Score (SAPS II) [ Time Frame: At postoperative day 7 after second liver operation ]
    Simplifies Acute Physiology Score (SAPS II)
  • Length of post-operative hospital stay [ Time Frame: 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 [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
    Criteria of internal standard operating procedures (SOP)
  • Pain [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    36-item short form health survey (SF-36)
  • Mortality [ Time Frame: after 90 days, after 182 days and after 365 days ]
    postoperative survival
  • Acute Physiological and Chronic Health Evaluation (Apache II) [ Time Frame: At postoperative day 7 after second liver operation ]
    Acute Physiological and Chronic Health Evaluation (Apache II)
  • Sequental Organ Failure Assessment (SOFA) [ Time Frame: At postoperative day 7 after second liver operation ]
    Sequental Organ Failure Assessment (SOFA)
  • TISS [ Time Frame: At postoperative day 7 after second liver operation ]
    Therapeutic Interventions Scoring System (TISS)
  • RASS [ Time Frame: At postoperative day 7 after second liver operation ]
    Richmonds Agitation Sedations Scale (RASS)
  • GCS [ Time Frame: At postoperative day 7 after second liver operation ]
    Glasgow Coma Scale (GCS)
  • RIFLE criteria [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    EuroQoL instrument (EQ-5D)
  • Change of Barthel Index: Instrumental Activity of Daily Living (ADL/IADL) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Barthel Index: Instrumental Activity of Daily Living (ADL/IADL)
  • Change of Instrumentelle Aktivität im täglichen Leben (IATL) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Instrumentelle Aktivität im täglichen Leben (IATL)
  • Change of Geriatric Depression Scale (GDS) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Geriatric Depression Scale (GDS)
  • Change of Cornell Depression Scale (CDS) [ Time Frame: 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) [ Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery ]
    Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cognitive Outcome After Two-stage Liver-Operation
Official Title Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy
Brief Summary Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult female and male patients undergoing two stage liver-operations
Condition Delirium and Post-operative Cognitive Dysfunction (POCD)
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 16, 2018)
23
Original Estimated Enrollment
 (submitted: March 11, 2013)
20
Actual Study Completion Date August 10, 2017
Actual Primary Completion Date April 16, 2017   (Final data collection date for primary outcome measure)
Eligibility 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

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01809782
Other Study ID Numbers Two-stage liver
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Claudia Spies, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
Collaborators Not Provided
Investigators
Study Director: Claudia Spies, MD Prof. Charite University, Berlin, Germany
PRS Account Charite University, Berlin, Germany
Verification Date January 2018