- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02759770
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
28. Januar 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
1333
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Beijing
-
Beijing, Beijing, China, 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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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Patients of cardiac surgery in Beijing Anzhen hospital
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Zeitfenster: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
Zeitfenster: 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.
Zeitfenster: up to 12months
|
up to 12months
|
|
The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
Zeitfenster: up to 12months
|
up to 12months
|
|
The number of diabetic patients in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The number of diabetic patients in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The number of chronic obstructive pulmonary disease patients in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The type of operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The type of operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The body mass index in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The body mass index in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The heart function in ARDS group before operation.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The heart function in non-ARDS group before operation.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation in ARDS group before operation.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation in non-ARDS group before operation.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The drug taken by patients in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The nutrition situation of patients in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The process of operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The process of operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The blood transfusion of patients during operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients during operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The drug taken by patients after operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The oxygenation of patients after operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
|
The situation of mechanical ventilation of patients after operation in non-ARDS group.
Zeitfenster: up to 1 month
|
up to 1 month
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Zeitfenster: up to 1months
|
up to 1months
|
|
The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
Zeitfenster: up to 1months
|
up to 1months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juli 2017
Primärer Abschluss (Tatsächlich)
30. September 2017
Studienabschluss (Tatsächlich)
30. September 2017
Studienanmeldedaten
Zuerst eingereicht
25. April 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. April 2016
Zuerst gepostet (Schätzen)
3. Mai 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Februar 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Januar 2021
Zuletzt verifiziert
1. Dezember 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Shoufa-2016-2-1052
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