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CESARO: Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT01964274
Collaborator
(none)
815
Enrollment
9
Locations
33
Actual Duration (Months)
90.6
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this prospective, multicenter observational study the investigators capture the perioperative course of peripheral cholinesterase activity. The focus is the perioperative inflammation causing postoperative delirium. Therefore we measure the activity of Acetylcholine-Esterase and Butyrylcholine-Esterase in whole blood of adults in the perioperative context. Early postoperative delirium will be detected by Nu-DESC in the Recovery Room or the Postanaesthesia-Care-Unit. The course of the peripheral cholinesterase activity will be compared with the incidence of postoperative delirium and other clinical dysfunctions.

We follow up the patients for up to five years regarding Delirum, comorbidities and mortality data.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    815 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
    Actual Study Start Date :
    Oct 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Surgical patients

    Adult male and female patients undergoing surgery

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Delirium [Participants will be followed in the sample period, an exspected average of three days]

      Postoperative Delirium (measured by Nursing Delirium Screening Scale)

    Secondary Outcome Measures

    1. Organ Dysfunctions [Participants will be followed in the sample period, an exspected average of three days]

    2. Concomitant medication [Participants will be followed in the three postoperative days sample period]

      Concomitant medications from Anticholinergic Drug Scale (ADS)

    3. Postoperative Pain [Participants will be followed in the three postoperative days sample period]

      According to Numeric Rating Scale

    4. Duration of Intensive Care Unit Stay [Participants will be followed in the sample period, an exspected average of seven days]

    5. Duration of Hospital Stay [Participants will be followed in the sample period, an exspected average of four weeks]

    6. Duration of Mechanical Ventilation [Participants will be followed in the sample period, an exspected average of 168 hours]

    7. Readmission rate [Participants will be followed in the sample period, an exspected average of four weeks]

    8. Hospital Treatment Data [Participations will be followed for the duration of the operation day, an exspected time average of eight hours]

      Operation time, surgery, anaesthesia

    9. Postoperative Mortality [Participants will be followed for the duration of the sample period an exspected average of five years]

      Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))

    10. Postoperative Delirium [Participants will be followed in the sample period, an exspected average of five years]

      Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))

    11. Comorbidities [Participants will be followed in the sample period, an exspected average of five years]

      Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female patients with age 18 years and above scheduled for surgery with planned stay in Recovery Room or Postanesthesia-Care-Unit

    • Offered patient information and written informed consent

    • In-hospital stay for at least 24 hours

    Exclusion Criteria:

    • Patients with known pseudocholinesterase deficiency

    • Participation in prospective intervention studies during the study period

    • Analphabetism

    • Unability of German and English language use

    • Anacusis or Hypoacusis with hearing aid device, Amaurosis

    • Lacking willingness to save and hand out data within the study

    • Accommodation in an institution due to an official or judicial order

    • Coworker of the clinic (study center)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin Berlin Germany 13353
    2 Department of Anesthesia, Klinik für MIC Berlin Germany 14129
    3 Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum Germany 44789
    4 Department of Anesthesiology, Universitätsklinikum Heidelberg Heidelberg Germany 69120
    5 Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich München Germany 81377
    6 Department of Anesthesiology, Universitätsklinikum Regensburg Regensburg Germany 93053
    7 Department of Anesthesiology, Universitätsklinikum Ulm Ulm Germany 89081
    8 Department of anesthesiology and intensive care medicine Wetzlar Germany 35578
    9 Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg Würzburg Germany 97080

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT01964274
    Other Study ID Numbers:
    • CESARO
    First Posted:
    Oct 17, 2013
    Last Update Posted:
    Aug 21, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany, Charite University, Berlin, Germany
    Nursing Delirium Screening Scale,
    Acetylcholinesterase Activity
    Additional relevant MeSH terms:
    Delirium
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Aug 21, 2019