Clinical trial NCT02759770: Risk Factors and Prediction Score of ARDS After Cardiac Surgery
Official title: Risk Factors and Prediction Score of ARDS After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Thoracic Surgery
Risk Factors
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 1333
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of cardiac surgery in Beijing Anzhen hospital

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
timeFrame: up to 12months
measure: The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.
timeFrame: up to 12months
measure: The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
timeFrame: up to 12months
measure: The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.
timeFrame: up to 12months
measure: The number of diabetic patients in ARDS group.
timeFrame: up to 1 month
measure: The number of diabetic patients in non-ARDS group.
timeFrame: up to 1 month
measure: The number of chronic obstructive pulmonary disease patients in ARDS group.
timeFrame: up to 1 month
measure: The number of chronic obstructive pulmonary disease patients in non-ARDS group.
timeFrame: up to 1 month
measure: The type of operation in ARDS group.
timeFrame: up to 1 month
measure: The type of operation in non-ARDS group.
timeFrame: up to 1 month
measure: The body mass index in ARDS group.
timeFrame: up to 1 month
measure: The body mass index in non-ARDS group.
timeFrame: up to 1 month
measure: The heart function in ARDS group before operation.
timeFrame: up to 1 month
measure: The heart function in non-ARDS group before operation.
timeFrame: up to 1 month
measure: The oxygenation in ARDS group before operation.
timeFrame: up to 1 month
measure: The oxygenation in non-ARDS group before operation.
timeFrame: up to 1 month
measure: The drug taken by patients in ARDS group.
timeFrame: up to 1 month
measure: The drug taken by patients in non-ARDS group.
timeFrame: up to 1 month
measure: The nutrition situation of patients in ARDS group.
timeFrame: up to 1 month
measure: The nutrition situation of patients in non-ARDS group.
timeFrame: up to 1 month
measure: The process of operation in ARDS group.
timeFrame: up to 1 month
measure: The process of operation in non-ARDS group.
timeFrame: up to 1 month
measure: The blood transfusion of patients during operation in ARDS group.
timeFrame: up to 1 month
measure: The blood transfusion of patients during operation in non-ARDS group.
timeFrame: up to 1 month
measure: The oxygenation of patients during operation in ARDS group.
timeFrame: up to 1 month
measure: The oxygenation of patients during operation in non-ARDS group.
timeFrame: up to 1 month
measure: The drug taken by patients after operation in ARDS group.
timeFrame: up to 1 month
measure: The drug taken by patients after operation in non-ARDS group.
timeFrame: up to 1 month
measure: The oxygenation of patients after operation in ARDS group.
timeFrame: up to 1 month
measure: The oxygenation of patients after operation in non-ARDS group.
timeFrame: up to 1 month
measure: The situation of mechanical ventilation of patients after operation in ARDS group.
timeFrame: up to 1 month
measure: The situation of mechanical ventilation of patients after operation in non-ARDS group.
timeFrame: up to 1 month
Secondary outcomes:
measure: The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
timeFrame: up to 1months
measure: The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .
timeFrame: up to 1months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
state: Beijing
Study officials:
affiliation: Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases
name: Guangfa Zhu
role: STUDY_CHAIR
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