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

• ClinicalTrials.gov Identifier: NCT01964274
• Recruitment Status: Completed
• First Posted: October 17, 2013
• Last Update Posted: August 21, 2019
• Sponsor: Charite University, Berlin, Germany
• 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

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 *

• Müller A, Olbert M, Heymann A, Zahn PK, Plaschke K, von Dossow V, Bitzinger D, Barth E, Meister M, Kranke P, Herrmann C, Wernecke KD, Spies CD. Relevance of peripheral cholinesterase activity on postoperative delirium in adult surgical patients (CESARO): A prospective observational cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):114-122. doi: 10.1097/EJA.0000000000000888.
• Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Müller A, Zausig YA, Bitzinger DI. Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study. BMJ Open. 2021 Jul 6;11(7):e042857. doi: 10.1136/bmjopen-2020-042857.

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

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