Delirium and Post-operative Cognitive Dysfunction (POCD)2-StaLiNCT01809782
Cognitive Outcome After Two-stage Liver-Operation
An observational study of Delirium and Post-operative Cognitive Dysfunction (POCD), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium and Post-operative Cognitive Dysfunction (POCD)
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2013to 10 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult female and male patients undergoing two stage liver-operations
Who may be able to join
- 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
- •Male and female ASA II/III patients, aged ≥ 18 years
Who cannot join
- 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
Show all 17Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum
Berlin, 13353
About this study
Official title: 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.
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
POCD
Measured by Cambridge Neurophysiological Test Automated Battery (CANTAB); calculated in relation to a healthy control group without intervention
Measured: At postoperative day 7 after second liver operation
Delirium
Measured by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)
Measured: At postoperative day 7 after second liver operation
Secondary outcomes (22)
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)
Measured: 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
Measured: Change from pre-operative (Baseline) up to 365 days after surgery
Simplifies Acute Physiology Score (SAPS II)
Simplifies Acute Physiology Score (SAPS II)
Measured: At postoperative day 7 after second liver operation
Length of post-operative hospital stay
Post-anaesthesia Discharge Scoring Stay (PADSS)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: Change from pre-operative (Baseline) up to 365 days after surgery
Mortality
postoperative survival
Measured: 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)
Measured: At postoperative day 7 after second liver operation
Sequental Organ Failure Assessment (SOFA)
Sequental Organ Failure Assessment (SOFA)
Measured: At postoperative day 7 after second liver operation
TISS
Therapeutic Interventions Scoring System (TISS)
Measured: At postoperative day 7 after second liver operation
RASS
Richmonds Agitation Sedations Scale (RASS)
Measured: At postoperative day 7 after second liver operation
GCS
Glasgow Coma Scale (GCS)
Measured: 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))
Measured: At postoperative day 7 after second liver operation
Change of EuroQoL instrument (EQ-5D)
EuroQoL instrument (EQ-5D)
Measured: 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)
Measured: 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)
Measured: Change from pre-operative (Baseline) up to 365 days after surgery
Change of Geriatric Depression Scale (GDS)
Geriatric Depression Scale (GDS)
Measured: Change from pre-operative (Baseline) up to 365 days after surgery
Change of Cornell Depression Scale (CDS)
Cornell Depression Scale (CDS)
Measured: 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)
Measured: Change from pre-operative (Baseline) up to 365 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study start11 Mar 2013
- Primary completion16 Apr 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium and Post-operative Cognitive Dysfunction (POCD)Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809782
- Sponsor's protocol ID
- Two-stage liver
- Acronym
- 2-StaLi
- Status last verified
- Jan 2018
- First submitted
- 26 Feb 2013
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Cognitive Dysfunction (POCD) and Delirium in Patients Undergoing Two-stage Liver Operation - a Pilotstudy
- ClinicalTrials.gov ID
- NCT01809782
- Acronym / sponsor ID
- 2-StaLi / Two-stage liver
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 11 Mar 2013 (actual)
- Primary completion
- 16 Apr 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female and male patients undergoing two stage liver-operations
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
22 secondary outcomes
Delirium
Time frame: At postoperative day 7 after second liver operation
Change of POCD
Time frame: 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
Length of post-operative hospital stay
Time frame: 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
Pain
Time frame: 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
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
Change of 36-item short form health survey (SF-36)
Time frame: Change from pre-operative (Baseline) up to 365 days after surgery
Mortality
Time frame: 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
Sequental Organ Failure Assessment (SOFA)
Time frame: At postoperative day 7 after second liver operation
TISS
Time frame: At postoperative day 7 after second liver operation
RASS
Time frame: At postoperative day 7 after second liver operation
GCS
Time frame: At postoperative day 7 after second liver operation
RIFLE criteria
Time frame: 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
Change of Barthel Index(for Activities of Daily Living, ADL)
Time frame: 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
Change of Geriatric Depression Scale (GDS)
Time frame: 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
Change of Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
Time frame: Change from pre-operative (Baseline) up to 365 days after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD Prof. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Post-operative Cognitive Dysfunction (POCD), run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCD (time frame: At postoperative day 7 after second liver operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.