Risk Factors and Prediction Score of ARDS After Cardiac Surgery
28 janvier 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Réel)
1333
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing
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Beijing, Beijing, Chine, 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients of cardiac surgery in Beijing Anzhen hospital
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
ARDS
ARDS patients after cardiac surgery
|
This is a clinical observational study, no intervention was included.
|
|
non-ARDS
non-ARDS patients after cardiac surgery
|
This is a clinical observational study, no intervention was included.
|
|
propective group
patients of cardiac surgery including ARDS and non-ARDS patients
|
This is a clinical observational study, no intervention was included.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Délai: 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.
Délai: 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.
Délai: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Délai: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The number of diabetic patients in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The type of operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The type of operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
Délai: up to 1 month
|
up to 1 month
|
|
The heart function in non-ARDS group before operation.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation in ARDS group before operation.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
Délai: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
Délai: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Délai: up to 1 month
|
up to 1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Délai: up to 1months
|
up to 1months
|
|
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Délai: up to 1months
|
up to 1months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juillet 2017
Achèvement primaire (Réel)
30 septembre 2017
Achèvement de l'étude (Réel)
30 septembre 2017
Dates d'inscription aux études
Première soumission
25 avril 2016
Première soumission répondant aux critères de contrôle qualité
29 avril 2016
Première publication (Estimation)
3 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 février 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 janvier 2021
Dernière vérification
1 décembre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Shoufa-2016-2-1052
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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