- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02759770
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
28 gennaio 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
1333
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Beijing
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Beijing, Beijing, Cina, 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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients of cardiac surgery in Beijing Anzhen hospital
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Lasso di tempo: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Lasso di tempo: 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.
Lasso di tempo: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Lasso di tempo: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The number of diabetic patients in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The type of operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The type of operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The heart function in non-ARDS group before operation.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation in ARDS group before operation.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Lasso di tempo: up to 1 month
|
up to 1 month
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Lasso di tempo: up to 1months
|
up to 1months
|
|
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Lasso di tempo: up to 1months
|
up to 1months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Cattedra di studio: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 luglio 2017
Completamento primario (Effettivo)
30 settembre 2017
Completamento dello studio (Effettivo)
30 settembre 2017
Date di iscrizione allo studio
Primo inviato
25 aprile 2016
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2016
Primo Inserito (Stima)
3 maggio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 febbraio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
28 gennaio 2021
Ultimo verificato
1 dicembre 2019
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Shoufa-2016-2-1052
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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