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

January 16, 2018 updated by: Claudia Spies, Charite University, Berlin, Germany

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At postoperative day 7 after second liver operation
Delirium
Time Frame: At postoperative day 7 after second liver operation
Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
At postoperative day 7 after second liver operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
At postoperative day 7 after second liver operation
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
Change from pre-operative (Baseline) up to 365 days after surgery
Simplifies Acute Physiology Score (SAPS II)
Time Frame: At postoperative day 7 after second liver operation
Simplifies Acute Physiology Score (SAPS II)
At postoperative day 7 after second liver operation
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)
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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)
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
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)
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
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
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
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
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)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
36-item short form health survey (SF-36)
Change from pre-operative (Baseline) up to 365 days after surgery
Mortality
Time Frame: after 90 days, after 182 days and after 365 days
postoperative survival
after 90 days, after 182 days and after 365 days
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)
At postoperative day 7 after second liver operation
Sequental Organ Failure Assessment (SOFA)
Time Frame: At postoperative day 7 after second liver operation
Sequental Organ Failure Assessment (SOFA)
At postoperative day 7 after second liver operation
TISS
Time Frame: At postoperative day 7 after second liver operation
Therapeutic Interventions Scoring System (TISS)
At postoperative day 7 after second liver operation
RASS
Time Frame: At postoperative day 7 after second liver operation
Richmonds Agitation Sedations Scale (RASS)
At postoperative day 7 after second liver operation
GCS
Time Frame: At postoperative day 7 after second liver operation
Glasgow Coma Scale (GCS)
At postoperative day 7 after second liver operation
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))
At postoperative day 7 after second liver operation
Change of EuroQoL instrument (EQ-5D)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
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)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
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)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
Instrumentelle Aktivität im täglichen Leben (IATL)
Change from pre-operative (Baseline) up to 365 days after surgery
Change of Geriatric Depression Scale (GDS)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
Geriatric Depression Scale (GDS)
Change from pre-operative (Baseline) up to 365 days after surgery
Change of Cornell Depression Scale (CDS)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
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)
Time Frame: Change from pre-operative (Baseline) up to 365 days after surgery
Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
Change from pre-operative (Baseline) up to 365 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Two-stage liver

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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