- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Berlin, 독일, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
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Berlin, 독일, 14129
- Department of Anesthesia, Klinik für MIC
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Bochum, 독일, 44789
- Clinic for Anaesthesiology, Intensive Care Medicine, Palliative Medicine and Pain Medicine, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
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Heidelberg, 독일, 69120
- Department of Anesthesiology, Universitätsklinikum Heidelberg
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München, 독일, 81377
- Department of Anesthesiology, Klinikum Großhadern of the Ludwig Maximilians University of Munich
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Regensburg, 독일, 93053
- Department of Anesthesiology, Universitätsklinikum Regensburg
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Ulm, 독일, 89081
- Department of Anesthesiology, Universitätsklinikum Ulm
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Wetzlar, 독일, 35578
- Department of anesthesiology and intensive care medicine
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Würzburg, 독일, 97080
- Department of Anaesthesia and Critical Care, Universitätsklinikum Würzburg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Surgical patients
Adult male and female patients undergoing surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Postoperative Delirium
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Organ Dysfunctions
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 책임자: Claudia Spies, MD, Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .