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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01964274
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Study Description
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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
Postoperative Delirium

Study Design
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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 : October 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Groups and Cohorts
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Group/Cohort
Surgical patients
Adult male and female patients undergoing surgery


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Delirium [ Time Frame: 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 [ Time Frame: Participants will be followed in the sample period, an exspected average of three days ]
  2. Concomitant medication [ Time Frame: Participants will be followed in the three postoperative days sample period ]
    Concomitant medications from Anticholinergic Drug Scale (ADS)

  3. Postoperative Pain [ Time Frame: Participants will be followed in the three postoperative days sample period ]
    According to Numeric Rating Scale

  4. Duration of Intensive Care Unit Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of seven days ]
  5. Duration of Hospital Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ]
  6. Duration of Mechanical Ventilation [ Time Frame: Participants will be followed in the sample period, an exspected average of 168 hours ]
  7. Readmission rate [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ]
  8. Hospital Treatment Data [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult, elective surgery patients of both gender
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964274


Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Department of Anesthesia, Klinik für MIC
Berlin, Germany, 14129
Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, Germany, 44789
Department of Anesthesiology, Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
München, Germany, 81377
Department of Anesthesiology, Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Department of Anesthesiology, Universitätsklinikum Ulm
Ulm, Germany, 89081
Department of anesthesiology and intensive care medicine
Wetzlar, Germany, 35578
Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Director: Claudia Spies, MD Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: October 17, 2013    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Keywords provided by Claudia Spies, Charite University, Berlin, Germany:
Nursing Delirium Screening Scale,
Acetylcholinesterase Activity
Additional relevant MeSH terms:
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Delirium
Emergence Delirium
Cognitive Dysfunction
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Cognition Disorders