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

19. august 2019 oppdatert av: Claudia Spies, Charite University, Berlin, Germany

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.

Studieoversikt

Status

Fullført

Forhold

Postoperativt delirium

Studietype

Observasjonsmessig

Registrering (Faktiske)

815

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Tyskland
- - Berlin, Tyskland, 13353
    - Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
  - Berlin, Tyskland, 14129
    - Department of Anesthesia, Klinik für MIC
  - Bochum, Tyskland, 44789
    - Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
  - Heidelberg, Tyskland, 69120
    - Department of Anesthesiology, Universitätsklinikum Heidelberg
  - München, Tyskland, 81377
    - Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
  - Regensburg, Tyskland, 93053
    - Department of Anesthesiology, Universitätsklinikum Regensburg
  - Ulm, Tyskland, 89081
    - Department of Anesthesiology, Universitätsklinikum Ulm
  - Wetzlar, Tyskland, 35578
    - Department of Anesthesiology and Intensive Care Medicine
  - Würzburg, Tyskland, 97080
    - Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Adult, elective surgery patients of both gender

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Surgical patients Adult male and female patients undergoing surgery

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Postoperative Delirium Tidsramme: Participants will be followed in the sample period, an exspected average of three days	Postoperative Delirium (measured by Nursing Delirium Screening Scale)	Participants will be followed in the sample period, an exspected average of three days

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Organ Dysfunctions Tidsramme: Participants will be followed in the sample period, an exspected average of three days		Participants will be followed in the sample period, an exspected average of three days
Concomitant medication Tidsramme: Participants will be followed in the three postoperative days sample period	Concomitant medications from Anticholinergic Drug Scale (ADS)	Participants will be followed in the three postoperative days sample period
Postoperative Pain Tidsramme: Participants will be followed in the three postoperative days sample period	According to Numeric Rating Scale	Participants will be followed in the three postoperative days sample period
Duration of Intensive Care Unit Stay Tidsramme: Participants will be followed in the sample period, an exspected average of seven days		Participants will be followed in the sample period, an exspected average of seven days
Duration of Hospital Stay Tidsramme: Participants will be followed in the sample period, an exspected average of four weeks		Participants will be followed in the sample period, an exspected average of four weeks
Duration of Mechanical Ventilation Tidsramme: Participants will be followed in the sample period, an exspected average of 168 hours		Participants will be followed in the sample period, an exspected average of 168 hours
Readmission rate Tidsramme: Participants will be followed in the sample period, an exspected average of four weeks		Participants will be followed in the sample period, an exspected average of four weeks
Hospital Treatment Data Tidsramme: Participations will be followed for the duration of the operation day, an exspected time average of eight hours	Operation time, surgery, anaesthesia	Participations will be followed for the duration of the operation day, an exspected time average of eight hours
Postoperative Mortality Tidsramme: 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))	Participants will be followed for the duration of the sample period an exspected average of five years
Postoperative Delirium Tidsramme: 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))	Participants will be followed in the sample period, an exspected average of five years
Comorbidities Tidsramme: 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)	Participants will be followed in the sample period, an exspected average of five years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Charite University, Berlin, Germany

Etterforskere

Studieleder: Claudia Spies, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2013

Primær fullføring (Faktiske)

1. juli 2016

Studiet fullført (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først innsendt

15. oktober 2013

Først innsendt som oppfylte QC-kriteriene