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NCT Number: NCT02759770

Risk Factors and Prediction Score of ARDS After Cardiac Surgery

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.

    Time frame: up to 12months

  2. The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.

    Time frame: up to 12months

  3. The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.

    Time frame: up to 12months

  4. The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.

    Time frame: up to 12months

  5. The number of diabetic patients in ARDS group.

    Time frame: up to 1 month

  6. The number of diabetic patients in non-ARDS group.

    Time frame: up to 1 month

  7. The number of chronic obstructive pulmonary disease patients in ARDS group.

    Time frame: up to 1 month

  8. The number of chronic obstructive pulmonary disease patients in non-ARDS group.

    Time frame: up to 1 month

  9. The type of operation in ARDS group.

    Time frame: up to 1 month

  10. The type of operation in non-ARDS group.

    Time frame: up to 1 month

  11. The body mass index in ARDS group.

    Time frame: up to 1 month

  12. The body mass index in non-ARDS group.

    Time frame: up to 1 month

  13. The heart function in ARDS group before operation.

    Time frame: up to 1 month

  14. The heart function in non-ARDS group before operation.

    Time frame: up to 1 month

  15. The oxygenation in ARDS group before operation.

    Time frame: up to 1 month

  16. The oxygenation in non-ARDS group before operation.

    Time frame: up to 1 month

  17. The drug taken by patients in ARDS group.

    Time frame: up to 1 month

  18. The drug taken by patients in non-ARDS group.

    Time frame: up to 1 month

  19. The nutrition situation of patients in ARDS group.

    Time frame: up to 1 month

  20. The nutrition situation of patients in non-ARDS group.

    Time frame: up to 1 month

  21. The process of operation in ARDS group.

    Time frame: up to 1 month

  22. The process of operation in non-ARDS group.

    Time frame: up to 1 month

  23. The blood transfusion of patients during operation in ARDS group.

    Time frame: up to 1 month

  24. The blood transfusion of patients during operation in non-ARDS group.

    Time frame: up to 1 month

  25. The oxygenation of patients during operation in ARDS group.

    Time frame: up to 1 month

  26. The oxygenation of patients during operation in non-ARDS group.

    Time frame: up to 1 month

  27. The drug taken by patients after operation in ARDS group.

    Time frame: up to 1 month

  28. The drug taken by patients after operation in non-ARDS group.

    Time frame: up to 1 month

  29. The oxygenation of patients after operation in ARDS group.

    Time frame: up to 1 month

  30. The oxygenation of patients after operation in non-ARDS group.

    Time frame: up to 1 month

  31. The situation of mechanical ventilation of patients after operation in ARDS group.

    Time frame: up to 1 month

  32. The situation of mechanical ventilation of patients after operation in non-ARDS group.

    Time frame: up to 1 month

Secondary outcomes

  1. The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .

    Time frame: up to 1months

  2. The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .

    Time frame: up to 1months

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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