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Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)

10. april 2018 oppdatert av: Ana Stevanovic, RWTH Aachen University

Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity Measured by Point of Care Method - a Prospective Observational Study

The purpose of this study is to assess the association between the "point-of-care" (POC) measured ChE activity (Acetylcholinesterase (ChE) + Buturylcholinesterase (ChE)) and postoperative delirium in elderly patients undergoing cardiac surgery.

Furthermore the investigators aim to identify factors, which influence the baseline levels and the time course of ChE activity.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Cardiac surgery in elderly patients is associated with serious complications, like increased morbidity, mortality and postoperative delirium with further hazardous consequences. The incidence of postoperative delirium in elderly is reported with a range from 36.6% - 54.9%. The pathophysiology of delirium is complex and the interaction of the cholinergic system and inflammation reaction is a relevant precipitant factor. It was suggested that there is a strong association between the perioperative plasma ChE activity and the inflammatory response in patients developing delirium. Patients showed a significant reduction of the total ChE activity after orthopaedic surgery, with significant lower pre- and postoperative values of AChE and BuChE and increased inflammatory response in patients developing postoperative delirium. It remains unclear if these results are applicable to other patient populations and which factors have influenced the low preoperative ChE levels. In patients suffering from a cardiac disease, a reduced total ChE respectively BuChE activity was significantly associated with mortality and long-term major adverse cardiovascular events. The investigators hypothesize that the ChE activity in peripheral blood can be used as a potential biomarker, to early detect patients at high risk for postoperative delirium.

Studietype

Observasjonsmessig

Registrering (Forventet)

100

Kontakter og plasseringer

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

Studiesteder

  • Tyskland
    • NRW
      • Aachen, NRW, Tyskland, 52074
        • Department of Anesthesiology, University Hospital Aachen

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

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Tertiary care clinic

Beskrivelse

Inclusion Criteria:

  • Written informed consent
  • ≥ 65 years of age
  • Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB
  • Both genders

Exclusion Criteria:

  • Planned deep hypothermic arrest
  • Acute / emergency procedures
  • Surgery without extracorporeal circulation (ECC)
  • Patients with a history of pseudocholinesterase deficiency
  • Employees of the respective study centres
  • Illiteracy
  • Severe communication difficulties and severe vision or hearing problems
  • Patients legally unable to give written informed consent
  • non-fluency in German language
  • Severe psychiatric or neuropsychiatric disorders
  • MMSE < 24 points, short geriatric depression scale (GDS) ≥ 10 points
  • Recent (<6 months) history of alcohol or drug abuse
  • The participation in a drug or device trial within the previous 30 days

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients undergoing cardiac surgery
Elderly patients scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of cardiopulmonary bypass.
Fremgangsmåte: Elective cardiac surgery
Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity
Tidsramme: 5 days
The perioperative AChE and BuChE activity will be assessed in the whole blood by a "point-of-care" measuring instrument (ChE check mobile ®) and the association to the incidence and duration of postoperative delirium will be determined. It will be assessed preoperative and maximum until the 5th postoperative day (POD), minimum until the 3.POD.
5 days
Delirium
Tidsramme: 5-45 days
Postoperative delirium will be assessed preoperative and daily with the CAM / CAM-ICU test until the 5.POD and on the discharge day from hospital. The incidence of postoperative delirium will be associated with the perioperative AChE and BuChE time course.
5-45 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pre-existing patient related risk factors
Tidsramme: 1 day
Influence of pre-existing patient related risk factors ( demographic data, medical and surgical history assessed preoperative) on postoperative delirium and the AChE and BuChE activity.
1 day
Identification of anticholinergic concomitant medication according to the PRISCUS list
Tidsramme: 1 day
Number of participants with preoperative anticholinergic medication
1 day
Survey of treatment associated data
Tidsramme: 45 days
Survey of treatment associated data until discharge (organ dysfunctions, postoperative pain, ICU length of stay, hospital length of stay, duration of mechanical ventilation, readmission rate to ICU, operation time, surgery, anaesthesia, intraoperative and postoperative volume load, postoperative mortality, comorbidities)
45 days
Cognitive function
Tidsramme: 45 days
Assessment of the cognitive function preoperative and on 3.POD and at discharge,by mini mental state examination (MMSE)
45 days
Routine venous blood parameters
Tidsramme: 5 days
Correlation of AChE and BuChE activity and routine venous blood parameters (Hb, Platelets, Leucocytes, INR, PTT, liver-enzymes (AST, ALT, y-GT, total Bilirubin), Creatinine, BUN, Albumin, sodium and potassium) and the influence on postoperative delirium
5 days
Inflammatory markers
Tidsramme: 5 days
Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium
5 days
Follow up measure of functional decline according to the IADL scale
Tidsramme: 180 days
Patients will be followed up by phone on the 30. and 180.POD. Association of AChE and BuChE activity and the functional decline on the 30. and 180.POD. The preoperative IADL scale will be compared to the data on the 30. and 180.POD to assess the functional decline
180 days
Follow up measure of mortality
Tidsramme: 180 days
Patients will be followed up by phone on the 30. and 180.POD. Determination of the association between the peri-operative AChE and BuChE activity and the mortality on the 30. and 180.POD
180 days
Follow up measure of the number of MACCE-events
Tidsramme: 180 days
Patients will be followed up by phone on the 30. and 180.POD. Association of AChE and BuChE activity and the postoperative major adverse cardiovascular and cerebral events (MACCE) on the 30. and 180.POD. The number of events will be assessed.
180 days
Health related quality of life
Tidsramme: 180 days
Health related quality of life measured by EuroQuol EQ-5D-5L test preoperative, on 30.POD and 180. POD
180 days
Instrumental activities of daily living
Tidsramme: 180 days
The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180. POD
180 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gender effect on delirium assessed by CAM-ICU/CAM
Tidsramme: 5-45 days
Analysis of the association of postoperative delirium until 5.POD respective discharge day and the gender of the patient
5-45 days
Gender effects on the peri-operative AChE and BuChE activity
Tidsramme: 5-45 days
Measurement of the AChE and BuChE activity until 3.-5.POD. Analysis of the association of the gender of the patient and the peri-operative time-course of the AChE and BuChE activity until the 3. respective 5.POD.
5-45 days
Postoperative bleeding
Tidsramme: 1 day
Measured 12 hours after surgery
1 day

Samarbeidspartnere og etterforskere

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

Sponsor

RWTH Aachen University

Etterforskere

  • Hovedetterforsker: Ana Stevanovic, MD, Department of Anesthesiology, University Hospital Aachen, Germany

Publikasjoner og nyttige lenker

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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. juli 2015

Primær fullføring (Faktiske)

1. mai 2016

Studiet fullført (Faktiske)

1. november 2016

Datoer for studieregistrering

Først innsendt

9. desember 2015

Først innsendt som oppfylte QC-kriteriene

11. desember 2015

Først lagt ut (Anslag)

16. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. april 2018

Sist bekreftet

1. april 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15-162

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