- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01964274
Relevance of the Peripheral Cholinesterase-activity on Neurocognitive Dysfunctions in Surgical Patients (CESARO)
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
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Berlin, Alemanha, 14129
- Department of Anesthesia, Klinik für MIC
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Bochum, Alemanha, 44789
- Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
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Heidelberg, Alemanha, 69120
- Department of Anesthesiology, Universitätsklinikum Heidelberg
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München, Alemanha, 81377
- Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
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Regensburg, Alemanha, 93053
- Department of Anesthesiology, Universitätsklinikum Regensburg
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Ulm, Alemanha, 89081
- Department of Anesthesiology, Universitätsklinikum Ulm
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Wetzlar, Alemanha, 35578
- Department of anesthesiology and intensive care medicine
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Würzburg, Alemanha, 97080
- Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Surgical patients
Adult male and female patients undergoing surgery
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Postoperative Delirium
Prazo: Participants will be followed in the sample period, an exspected average of three days
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Postoperative Delirium (measured by Nursing Delirium Screening Scale)
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Participants will be followed in the sample period, an exspected average of three days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Organ Dysfunctions
Prazo: Participants will be followed in the sample period, an exspected average of three days
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Participants will be followed in the sample period, an exspected average of three days
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Concomitant medication
Prazo: Participants will be followed in the three postoperative days sample period
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Concomitant medications from Anticholinergic Drug Scale (ADS)
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Participants will be followed in the three postoperative days sample period
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Postoperative Pain
Prazo: Participants will be followed in the three postoperative days sample period
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According to Numeric Rating Scale
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Participants will be followed in the three postoperative days sample period
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Duration of Intensive Care Unit Stay
Prazo: Participants will be followed in the sample period, an exspected average of seven days
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Participants will be followed in the sample period, an exspected average of seven days
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Duration of Hospital Stay
Prazo: Participants will be followed in the sample period, an exspected average of four weeks
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Participants will be followed in the sample period, an exspected average of four weeks
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Duration of Mechanical Ventilation
Prazo: Participants will be followed in the sample period, an exspected average of 168 hours
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Participants will be followed in the sample period, an exspected average of 168 hours
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Readmission rate
Prazo: Participants will be followed in the sample period, an exspected average of four weeks
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Participants will be followed in the sample period, an exspected average of four weeks
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Hospital Treatment Data
Prazo: Participations will be followed for the duration of the operation day, an exspected time average of eight hours
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Operation time, surgery, anaesthesia
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Participations will be followed for the duration of the operation day, an exspected time average of eight hours
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Postoperative Mortality
Prazo: Participants will be followed for the duration of the sample period an exspected average of five years
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Mortality (measured inhouse-mortality according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG))
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Participants will be followed for the duration of the sample period an exspected average of five years
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Postoperative Delirium
Prazo: Participants will be followed in the sample period, an exspected average of five years
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Postoperative Delirium (measured by Diagnosis of Delirium according to the patients´records and based on the data record according to §21 Krankenhausentgeltgesetz -(KHEntgG))
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Participants will be followed in the sample period, an exspected average of five years
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Comorbidities
Prazo: Participants will be followed in the sample period, an exspected average of five years
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Comorbidities based on the data record according to §21 Krankenhausentgeltgesetz - (KHEntgG)
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Participants will be followed in the sample period, an exspected average of five years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Claudia Spies, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
Publicações e links úteis
Publicações Gerais
- Muller A, Olbert M, Heymann A, Zahn PK, Plaschke K, von Dossow V, Bitzinger D, Barth E, Meister M, Kranke P, Herrmann C, Wernecke KD, Spies CD. Relevance of peripheral cholinesterase activity on postoperative delirium in adult surgical patients (CESARO): A prospective observational cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):114-122. doi: 10.1097/EJA.0000000000000888.
- Michels B, Holzamer A, Graf BM, Bredthauer A, Petermichl W, Muller A, Zausig YA, Bitzinger DI. Butyrylcholinesterase as a perioperative complication marker in patients after transcatheter aortic valve implantation: a prospective observational study. BMJ Open. 2021 Jul 6;11(7):e042857. doi: 10.1136/bmjopen-2020-042857.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CESARO
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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