Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

19 augusti 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Postoperativt delirium

Studietyp

Observationell

Inskrivning (Faktisk)

815

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

Adult, elective surgery patients of both gender

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Postoperative Delirium Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Organ Dysfunctions Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Charite University, Berlin, Germany

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 oktober 2013

Primärt slutförande (Faktisk)

1 juli 2016

Avslutad studie (Faktisk)

1 juli 2016

Studieregistreringsdatum

Först inskickad

15 oktober 2013

Först inskickad som uppfyllde QC-kriterierna