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

Postoperative Delirium Clinical Trial

— CESARO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964274
• Other study ID #: CESARO
• Status: Completed
• Start date: October 2013
• Est. completion date: July 2016

Study information

• Verified date: August 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Germany	Department of Anesthesia, Klinik für MIC	Berlin
Germany	Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin	Berlin
Germany	Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil	Bochum
Germany	Department of Anesthesiology, Universitätsklinikum Heidelberg	Heidelberg
Germany	Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich	München
Germany	Department of Anesthesiology, Universitätsklinikum Regensburg	Regensburg
Germany	Department of Anesthesiology, Universitätsklinikum Ulm	Ulm
Germany	Department of anesthesiology and intensive care medicine	Wetzlar
Germany	Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Delirium	Postoperative Delirium (measured by Nursing Delirium Screening Scale)	Participants will be followed in the sample period, an exspected average of three days
Secondary	Organ Dysfunctions		Participants will be followed in the sample period, an exspected average of three days
Secondary	Concomitant medication	Concomitant medications from Anticholinergic Drug Scale (ADS)	Participants will be followed in the three postoperative days sample period
Secondary	Postoperative Pain	According to Numeric Rating Scale	Participants will be followed in the three postoperative days sample period
Secondary	Duration of Intensive Care Unit Stay		Participants will be followed in the sample period, an exspected average of seven days
Secondary	Duration of Hospital Stay		Participants will be followed in the sample period, an exspected average of four weeks
Secondary	Duration of Mechanical Ventilation		Participants will be followed in the sample period, an exspected average of 168 hours
Secondary	Readmission rate		Participants will be followed in the sample period, an exspected average of four weeks
Secondary	Hospital Treatment Data	Operation time, surgery, anaesthesia	Participations will be followed for the duration of the operation day, an exspected time average of eight hours
Secondary	Postoperative Mortality	Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))	Participants will be followed for the duration of the sample period an exspected average of five years
Secondary	Postoperative Delirium	Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))	Participants will be followed in the sample period, an exspected average of five years
Secondary	Comorbidities	Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)	Participants will be followed in the sample period, an exspected average of five years