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

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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

Tracking Information
First Submitted Date October 15, 2013
First Posted Date October 17, 2013
Last Update Posted Date August 21, 2019
Actual Study Start Date October 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2013)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 15, 2013)
  • Organ Dysfunctions [ Time Frame: Participants will be followed in the sample period, an exspected average of three days ]
  • Concomitant medication [ Time Frame: Participants will be followed in the three postoperative days sample period ]
    Concomitant medications from Anticholinergic Drug Scale (ADS)
  • Postoperative Pain [ Time Frame: Participants will be followed in the three postoperative days sample period ]
    According to Numeric Rating Scale
  • Duration of Intensive Care Unit Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of seven days ]
  • Duration of Hospital Stay [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ]
  • Duration of Mechanical Ventilation [ Time Frame: Participants will be followed in the sample period, an exspected average of 168 hours ]
  • Readmission rate [ Time Frame: Participants will be followed in the sample period, an exspected average of four weeks ]
  • 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
  • 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))
  • 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))
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
Official Title Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult, elective surgery patients of both gender
Condition Postoperative Delirium
Intervention Not Provided
Study Groups/Cohorts Surgical patients
Adult male and female patients undergoing surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 9, 2016)
815
Original Estimated Enrollment
 (submitted: October 15, 2013)
800
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01964274
Other Study ID Numbers CESARO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Claudia Spies, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
Collaborators Not Provided
Investigators
Study Director: Claudia Spies, MD Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date August 2019