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

19. august 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

815

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Charite University, Berlin, Germany

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. juli 2016

Studieafslutning (Faktiske)

1. juli 2016

Datoer for studieregistrering

Først indsendt

15. oktober 2013

Først indsendt, der opfyldte QC-kriterier

15. oktober 2013

Først opslået (Skøn)

17. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2019

Sidst verificeret

1. august 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CESARO

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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