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

NCT ID: NCT01964274

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

815 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Postoperative Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical patients

Adult male and female patients undergoing surgery

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Spies, MD

Role: STUDY_DIRECTOR

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Locations

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Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Department of Anesthesia, Klinik für MIC

Berlin, , Germany

Site Status

Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, , Germany

Site Status

Department of Anesthesiology, Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich

München, , Germany

Site Status

Department of Anesthesiology, Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status

Department of Anesthesiology, Universitätsklinikum Ulm

Ulm, , Germany

Site Status

Department of anesthesiology and intensive care medicine

Wetzlar, , Germany

Site Status

Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 30431498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34230011 (View on PubMed)

Other Identifiers

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CESARO

Identifier Type: -

Identifier Source: org_study_id

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