Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
10 avril 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Anticipé)
100
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
NRW
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Aachen, NRW, Allemagne, 52074
- Department of Anesthesiology, University Hospital Aachen
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Tertiary care clinic
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
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Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pre-existing patient related risk factors
Délai: 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.
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1 day
|
|
Identification of anticholinergic concomitant medication according to the PRISCUS list
Délai: 1 day
|
Number of participants with preoperative anticholinergic medication
|
1 day
|
|
Survey of treatment associated data
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 180 days
|
The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180.
POD
|
180 days
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gender effect on delirium assessed by CAM-ICU/CAM
Délai: 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
|
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Gender effects on the peri-operative AChE and BuChE activity
Délai: 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.
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5-45 days
|
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Postoperative bleeding
Délai: 1 day
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Measured 12 hours after surgery
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1 day
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Ana Stevanovic, MD, Department of Anesthesiology, University Hospital Aachen, Germany
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Smulter N, Lingehall HC, Gustafson Y, Olofsson B, Engstrom KG. Delirium after cardiac surgery: incidence and risk factors. Interact Cardiovasc Thorac Surg. 2013 Nov;17(5):790-6. doi: 10.1093/icvts/ivt323. Epub 2013 Jul 25.
- Cerejeira J, Batista P, Nogueira V, Firmino H, Vaz-Serra A, Mukaetova-Ladinska EB. Low preoperative plasma cholinesterase activity as a risk marker of postoperative delirium in elderly patients. Age Ageing. 2011 Sep;40(5):621-6. doi: 10.1093/ageing/afr053. Epub 2011 May 15.
- Rudolph JL, Inouye SK, Jones RN, Yang FM, Fong TG, Levkoff SE, Marcantonio ER. Delirium: an independent predictor of functional decline after cardiac surgery. J Am Geriatr Soc. 2010 Apr;58(4):643-9. doi: 10.1111/j.1532-5415.2010.02762.x. Epub 2010 Mar 22.
- Cerejeira J, Lagarto L, Mukaetova-Ladinska EB. The immunology of delirium. Neuroimmunomodulation. 2014;21(2-3):72-8. doi: 10.1159/000356526. Epub 2014 Feb 14.
- Distelmaier K, Winter MP, Rutzler K, Heinz G, Lang IM, Maurer G, Koinig H, Steinlechner B, Niessner A, Goliasch G. Serum butyrylcholinesterase predicts survival after extracorporeal membrane oxygenation after cardiovascular surgery. Crit Care. 2014 Jan 30;18(1):R24. doi: 10.1186/cc13711.
- Arbel Y, Shenhar-Tsarfaty S, Waiskopf N, Finkelstein A, Halkin A, Revivo M, Berliner S, Herz I, Shapira I, Keren G, Soreq H, Banai S. Decline in serum cholinesterase activities predicts 2-year major adverse cardiac events. Mol Med. 2014 Feb 12;20(1):38-45. doi: 10.2119/molmed.2013.00139.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2015
Achèvement primaire (Réel)
1 mai 2016
Achèvement de l'étude (Réel)
1 novembre 2016
Dates d'inscription aux études
Première soumission
9 décembre 2015
Première soumission répondant aux critères de contrôle qualité
11 décembre 2015
Première publication (Estimation)
16 décembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 avril 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 avril 2018
Dernière vérification
1 avril 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-162
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .