Clinical trial NCT01809782: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Delirium and Post-operative Cognitive Dysfunction (POCD)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult female and male patients undergoing two stage liver-operations

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


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

Primary outcomes:
measure: POCD
timeFrame: At postoperative day 7 after second liver operation
measure: Delirium
timeFrame: At postoperative day 7 after second liver operation
Secondary outcomes:
measure: Delirium
timeFrame: At postoperative day 7 after second liver operation
measure: Change of POCD
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Simplifies Acute Physiology Score (SAPS II)
timeFrame: At postoperative day 7 after second liver operation
measure: Length of post-operative hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Length of post-operative intensive care unit stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: Pain
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: The rate of post-operative organ dysfunctions and complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Incidence of systemic inflammatory response syndrome (SIRS) and infection
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Change of 36-item short form health survey (SF-36)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Mortality
timeFrame: after 90 days, after 182 days and after 365 days
measure: Acute Physiological and Chronic Health Evaluation (Apache II)
timeFrame: At postoperative day 7 after second liver operation
measure: Sequental Organ Failure Assessment (SOFA)
timeFrame: At postoperative day 7 after second liver operation
measure: TISS
timeFrame: At postoperative day 7 after second liver operation
measure: RASS
timeFrame: At postoperative day 7 after second liver operation
measure: GCS
timeFrame: At postoperative day 7 after second liver operation
measure: RIFLE criteria
timeFrame: At postoperative day 7 after second liver operation
measure: Change of EuroQoL instrument (EQ-5D)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Change of Barthel Index(for Activities of Daily Living, ADL)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Change of Instrumentelle Aktivität im täglichen Leben (IATL)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Change of Geriatric Depression Scale (GDS)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Change of Cornell Depression Scale (CDS)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
measure: Change of Hospital Anxiety and Depression Scale deutsche Version (HADS-D)
timeFrame: Change from pre-operative (Baseline) up to 365 days after surgery
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References: