Risk Factors and Prediction Score of ARDS After Cardiac Surgery

NCT ID: NCT02759770

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult Thoracic Surgery Risk Factors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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ARDS

ARDS patients after cardiac surgery

no intervention

Intervention Type OTHER

This is a clinical observational study, no intervention was included.

non-ARDS

non-ARDS patients after cardiac surgery

no intervention

Intervention Type OTHER

This is a clinical observational study, no intervention was included.

propective group

patients of cardiac surgery including ARDS and non-ARDS patients

no intervention

Intervention Type OTHER

This is a clinical observational study, no intervention was included.

Interventions

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no intervention

This is a clinical observational study, no intervention was included.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guangfa Zhu

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guangfa Zhu

Role: STUDY_CHAIR

Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Locations

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Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24299028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21288212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22524447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25599463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25501020 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25478722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25288000 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22797452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11243972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16390572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25597606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24755786 (View on PubMed)

Other Identifiers

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Shoufa-2016-2-1052

Identifier Type: -

Identifier Source: org_study_id

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