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

2019年8月19日更新者：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.

研究概览

地位

完全的

条件

术后谵妄

研究类型

观察性的

注册 (实际的)

815

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

德国
- - Berlin、德国、13353
    - Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
  - Berlin、德国、14129
    - Department of Anesthesia, Klinik für MIC
  - Bochum、德国、44789
    - Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
  - Heidelberg、德国、69120
    - Department of Anesthesiology, Universitätsklinikum Heidelberg
  - München、德国、81377
    - Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
  - Regensburg、德国、93053
    - Department of Anesthesiology, Universitätsklinikum Regensburg
  - Ulm、德国、89081
    - Department of Anesthesiology, Universitätsklinikum Ulm
  - Wetzlar、德国、35578
    - Department of anesthesiology and intensive care medicine
  - Würzburg、德国、97080
    - Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult, elective surgery patients of both gender

描述

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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Surgical patients Adult male and female patients undergoing surgery

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Postoperative Delirium 大体时间：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

次要结果测量

结果测量	措施说明	大体时间
Organ Dysfunctions 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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 大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Charite University, Berlin, Germany

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年10月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2013年10月15日

首先提交符合 QC 标准的

2013年10月15日

首次发布 (估计)

2013年10月17日

研究记录更新

最后更新发布 (实际的)

2019年8月21日

上次提交的符合 QC 标准的更新

2019年8月19日

最后验证

2019年8月1日