- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02631304
Delirium in Elderly Undergoing Cardiac Surgery and the Significance of CholinEsterase Activity (DECCEP)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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NRW
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Aachen, NRW, Germania, 52074
- Department of Anesthesiology, University Hospital Aachen
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Acetylcholinesterase (AChE) and buturylcholinesterase (BuChE) activity
Lasso di tempo: 5 days
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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.
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5 days
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Delirium
Lasso di tempo: 5-45 days
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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.
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5-45 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Pre-existing patient related risk factors
Lasso di tempo: 1 day
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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
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Identification of anticholinergic concomitant medication according to the PRISCUS list
Lasso di tempo: 1 day
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Number of participants with preoperative anticholinergic medication
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1 day
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Survey of treatment associated data
Lasso di tempo: 45 days
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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)
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45 days
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Cognitive function
Lasso di tempo: 45 days
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Assessment of the cognitive function preoperative and on 3.POD and at discharge,by mini mental state examination (MMSE)
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45 days
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Routine venous blood parameters
Lasso di tempo: 5 days
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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
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5 days
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Inflammatory markers
Lasso di tempo: 5 days
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Correlation of AChE and BuChE activity to inflammatory markers in serum and the influence on postoperative delirium
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5 days
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Follow up measure of functional decline according to the IADL scale
Lasso di tempo: 180 days
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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
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180 days
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Follow up measure of mortality
Lasso di tempo: 180 days
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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
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180 days
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Follow up measure of the number of MACCE-events
Lasso di tempo: 180 days
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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.
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180 days
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Health related quality of life
Lasso di tempo: 180 days
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Health related quality of life measured by EuroQuol EQ-5D-5L test preoperative, on 30.POD and 180.
POD
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180 days
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Instrumental activities of daily living
Lasso di tempo: 180 days
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The Lawton Instrumental Activities of Daily Living (IADL) Scale measured preoperative, on 30.POD and 180.
POD
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180 days
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Gender effect on delirium assessed by CAM-ICU/CAM
Lasso di tempo: 5-45 days
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Analysis of the association of postoperative delirium until 5.POD respective discharge day and the gender of the patient
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5-45 days
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Gender effects on the peri-operative AChE and BuChE activity
Lasso di tempo: 5-45 days
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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
Lasso di tempo: 1 day
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Measured 12 hours after surgery
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1 day
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ana Stevanovic, MD, Department of Anesthesiology, University Hospital Aachen, Germany
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15-162
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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