Clinical trial NCT01964274: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: Nursing Delirium Screening Scale,
Acetylcholinesterase Activity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult, elective surgery patients of both gender

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.


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)

Primary outcomes:
measure: Postoperative Delirium
timeFrame: Participants will be followed in the sample period, an exspected average of three days
Secondary outcomes:
measure: Organ Dysfunctions
timeFrame: Participants will be followed in the sample period, an exspected average of three days
measure: Concomitant medication
timeFrame: Participants will be followed in the three postoperative days sample period
measure: Postoperative Pain
timeFrame: Participants will be followed in the three postoperative days sample period
measure: Duration of Intensive Care Unit Stay
timeFrame: Participants will be followed in the sample period, an exspected average of seven days
measure: Duration of Hospital Stay
timeFrame: Participants will be followed in the sample period, an exspected average of four weeks
measure: Duration of Mechanical Ventilation
timeFrame: Participants will be followed in the sample period, an exspected average of 168 hours
measure: Readmission rate
timeFrame: Participants will be followed in the sample period, an exspected average of four weeks
measure: Hospital Treatment Data
timeFrame: Participations will be followed for the duration of the operation day, an exspected time average of eight hours
measure: Postoperative Mortality
timeFrame: Participants will be followed for the duration of the sample period an exspected average of five years
measure: Postoperative Delirium
timeFrame: Participants will be followed in the sample period, an exspected average of five years
measure: Comorbidities
timeFrame: Participants will be followed in the sample period, an exspected average of five years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Department of Anesthesia, Klinik für MIC
city: Bochum
country: Germany
facility: Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
city: Heidelberg
country: Germany
facility: Department of Anesthesiology, Universitätsklinikum Heidelberg
city: München
country: Germany
facility: Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
city: Regensburg
country: Germany
facility: Department of Anesthesiology, Universitätsklinikum Regensburg
city: Ulm
country: Germany
facility: Department of Anesthesiology, Universitätsklinikum Ulm
city: Wetzlar
country: Germany
facility: Department of anesthesiology and intensive care medicine
city: Würzburg
country: Germany
facility: Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
name: Claudia Spies, MD
role: STUDY_DIRECTOR
References:
citation: Muller 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.
citation: Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Muller 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.