- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02759770
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
2021년 1월 28일 업데이트: Guangfa Zhu, Beijing Anzhen Hospital
Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%.
Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures.
It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients.
According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality.
So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less.
Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome.
As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery.
This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures.
This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.
연구 개요
연구 유형
관찰
등록 (실제)
1333
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing
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Beijing, Beijing, 중국, 100029
- Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients of cardiac surgery in Beijing Anzhen hospital
설명
Inclusion Criteria:
- Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
- Prospective group: cardiac surgery patients accepted from 2017 January to December
Exclusion Criteria:
- refused to participate in the study
- age less than 18 years old
- before operation performed mechanical ventilation
- before operation underwent IABP treatment
- before operation continuous renal replacement therapy
- before operation undergoing in vitro membrane oxygenator treatment
- before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure
- the major trauma, sepsis, aspiration, shock, acute heart failure
- before operation diagnosed as malignant tumor
- Incomplete data.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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ARDS
ARDS patients after cardiac surgery
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This is a clinical observational study, no intervention was included.
|
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non-ARDS
non-ARDS patients after cardiac surgery
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This is a clinical observational study, no intervention was included.
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propective group
patients of cardiac surgery including ARDS and non-ARDS patients
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This is a clinical observational study, no intervention was included.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
기간: up to 12months
|
up to 12months
|
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The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
기간: up to 12months
|
up to 12months
|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
기간: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
기간: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The number of diabetic patients in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The type of operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The type of operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
기간: up to 1 month
|
up to 1 month
|
|
The heart function in non-ARDS group before operation.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation in ARDS group before operation.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
기간: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
기간: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
기간: up to 1 month
|
up to 1 month
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
기간: up to 1months
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up to 1months
|
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The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
기간: up to 1months
|
up to 1months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Kogan A, Preisman S, Levin S, Raanani E, Sternik L. Adult respiratory distress syndrome following cardiac surgery. J Card Surg. 2014 Jan;29(1):41-6. doi: 10.1111/jocs.12264. Epub 2013 Dec 3.
- Berg KS, Stenseth R, Pleym H, Wahba A, Videm V. Mortality risk prediction in cardiac surgery: comparing a novel model with the EuroSCORE. Acta Anaesthesiol Scand. 2011 Mar;55(3):313-21. doi: 10.1111/j.1399-6576.2010.02393.x.
- Forel JM, Voillet F, Pulina D, Gacouin A, Perrin G, Barrau K, Jaber S, Arnal JM, Fathallah M, Auquier P, Roch A, Azoulay E, Papazian L. Ventilator-associated pneumonia and ICU mortality in severe ARDS patients ventilated according to a lung-protective strategy. Crit Care. 2012 Dec 12;16(2):R65. doi: 10.1186/cc11312.
- Grissom CK, Hirshberg EL, Dickerson JB, Brown SM, Lanspa MJ, Liu KD, Schoenfeld D, Tidswell M, Hite RD, Rock P, Miller RR 3rd, Morris AH; National Heart Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network. Fluid management with a simplified conservative protocol for the acute respiratory distress syndrome*. Crit Care Med. 2015 Feb;43(2):288-95. doi: 10.1097/CCM.0000000000000715.
- Festic E, Kor DJ, Gajic O. Prevention of acute respiratory distress syndrome. Curr Opin Crit Care. 2015 Feb;21(1):82-90. doi: 10.1097/MCC.0000000000000174.
- Rubenfeld GD. Who cares about preventing acute respiratory distress syndrome? Am J Respir Crit Care Med. 2015 Feb 1;191(3):255-60. doi: 10.1164/rccm.201408-1574CP.
- Beitler JR, Schoenfeld DA, Thompson BT. Preventing ARDS: progress, promise, and pitfalls. Chest. 2014 Oct;146(4):1102-1113. doi: 10.1378/chest.14-0555.
- Milot J, Perron J, Lacasse Y, Letourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. doi: 10.1378/chest.119.3.884.
- Michalopoulos A, Prapas S, Falagas ME. The incidence of adult respiratory distress syndrome in patients undergoing off-pump coronary artery bypass grafting surgery. Eur J Anaesthesiol. 2006 Jan;23(1):80. doi: 10.1017/S0265021505211821. No abstract available.
- Vakili M, Shirani S, Paknejad O, Yousefshahi F. Acute Respiratory Distress Syndrome diagnosis after coronary artery bypass: comparison between diagnostic criteria and clinical picture. Acta Med Iran. 2015;53(1):51-6.
- Kor DJ, Lingineni RK, Gajic O, Park PK, Blum JM, Hou PC, Hoth JJ, Anderson HL 3rd, Bajwa EK, Bartz RR, Adesanya A, Festic E, Gong MN, Carter RE, Talmor DS. Predicting risk of postoperative lung injury in high-risk surgical patients: a multicenter cohort study. Anesthesiology. 2014 May;120(5):1168-81. doi: 10.1097/ALN.0000000000000216.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 7월 1일
기본 완료 (실제)
2017년 9월 30일
연구 완료 (실제)
2017년 9월 30일
연구 등록 날짜
최초 제출
2016년 4월 25일
QC 기준을 충족하는 최초 제출
2016년 4월 29일
처음 게시됨 (추정)
2016년 5월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 2월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 28일
마지막으로 확인됨
2019년 12월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Shoufa-2016-2-1052
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. .
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