- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02571920
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)
연구 개요
상태
상세 설명
The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.
However, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.
The investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.
The main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.
Secondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Caen, 프랑스
- Caen University hospital
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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:
- Patients over 18 years old undergoing cardiac surgery during the study period
Non-inclusion Criteria:
- age under 18 years old
- Extracorporeal life support and others cardiac assistance
- congenital cardiac surgery
- TAVI procedures
- Pericardium surgical drainages
- Sternal sepsis surgery
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the incidence of dobutamine use
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the incidence of epinephrine use
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the length of dobutamine infusion
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of cardiac output monitoring and the length of epinephrine infusion
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
기간: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Marc-Olivier Fischer, University Hospital, Caen
- 수석 연구원: Fabien Dechanet, University Hospital, Caen
- 수석 연구원: Raphaël D'Orlando, University Hospital, Caen
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
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