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临床试验/NCT01964274
NCT01964274已完成不适用

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

Charite University, Berlin, Germany9 个研究点 分布在 1 个国家目标入组 815 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
815
试验地点
9
主要终点
Postoperative Delirium

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Postoperative Delirium

时间窗: Participants will be followed in the sample period, an exspected average of three days

Postoperative Delirium (measured by Nursing Delirium Screening Scale)

次要结局

  • Organ Dysfunctions(Participants will be followed in the sample period, an exspected average of three days)
  • Concomitant medication(Participants will be followed in the three postoperative days sample period)
  • Postoperative Pain(Participants will be followed in the three postoperative days sample period)
  • Duration of Intensive Care Unit Stay(Participants will be followed in the sample period, an exspected average of seven days)
  • Duration of Mechanical Ventilation(Participants will be followed in the sample period, an exspected average of 168 hours)
  • Readmission rate(Participants will be followed in the sample period, an exspected average of four weeks)
  • Postoperative Mortality(Participants will be followed for the duration of the sample period an exspected average of five years)
  • Duration of Hospital Stay(Participants will be followed in the sample period, an exspected average of four weeks)
  • Hospital Treatment Data(Participations will be followed for the duration of the operation day, an exspected time average of eight hours)
  • Postoperative Delirium(Participants will be followed in the sample period, an exspected average of five years)
  • Comorbidities(Participants will be followed in the sample period, an exspected average of five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite - Universitätsmedizin Berlin, Germany

Charite University, Berlin, Germany

研究点 (9)

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