- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02759770
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
28. januar 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
1333
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients of cardiac surgery in Beijing Anzhen hospital
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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.
|
|
propective group
patients of cardiac surgery including ARDS and non-ARDS patients
|
This is a clinical observational study, no intervention was included.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Tidsramme: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Tidsramme: 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.
Tidsramme: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Tidsramme: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The number of diabetic patients in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The type of operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The type of operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The heart function in non-ARDS group before operation.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation in ARDS group before operation.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Tidsramme: up to 1 month
|
up to 1 month
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Tidsramme: up to 1months
|
up to 1months
|
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The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Tidsramme: up to 1months
|
up to 1months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2017
Primær fullføring (Faktiske)
30. september 2017
Studiet fullført (Faktiske)
30. september 2017
Datoer for studieregistrering
Først innsendt
25. april 2016
Først innsendt som oppfylte QC-kriteriene
29. april 2016
Først lagt ut (Anslag)
3. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. februar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. januar 2021
Sist bekreftet
1. desember 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Shoufa-2016-2-1052
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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