Risk Factors and Prediction Score of ARDS After Cardiac Surgery

Sponsor
Beijing Anzhen Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02759770
Collaborator
(none)
1,333
1
3
445.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention

Study Design

Study Type:
Observational
Actual Enrollment :
1333 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Risk Factors and Prediction Score of ARDS After Cardiac Surgery
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Sep 30, 2017

Arms and Interventions

Arm Intervention/Treatment
ARDS

ARDS patients after cardiac surgery

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

non-ARDS

non-ARDS patients after cardiac surgery

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

propective group

patients of cardiac surgery including ARDS and non-ARDS patients

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

Outcome Measures

Primary Outcome Measures

  1. The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015. [up to 12months]

  2. The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015. [up to 12months]

  3. The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017. [up to 12months]

  4. The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017. [up to 12months]

  5. The number of diabetic patients in ARDS group. [up to 1 month]

  6. The number of diabetic patients in non-ARDS group. [up to 1 month]

  7. The number of chronic obstructive pulmonary disease patients in ARDS group. [up to 1 month]

  8. The number of chronic obstructive pulmonary disease patients in non-ARDS group. [up to 1 month]

  9. The type of operation in ARDS group. [up to 1 month]

  10. The type of operation in non-ARDS group. [up to 1 month]

  11. The body mass index in ARDS group. [up to 1 month]

  12. The body mass index in non-ARDS group. [up to 1 month]

  13. The heart function in ARDS group before operation. [up to 1 month]

  14. The heart function in non-ARDS group before operation. [up to 1 month]

  15. The oxygenation in ARDS group before operation. [up to 1 month]

  16. The oxygenation in non-ARDS group before operation. [up to 1 month]

  17. The drug taken by patients in ARDS group. [up to 1 month]

  18. The drug taken by patients in non-ARDS group. [up to 1 month]

  19. The nutrition situation of patients in ARDS group. [up to 1 month]

  20. The nutrition situation of patients in non-ARDS group. [up to 1 month]

  21. The process of operation in ARDS group. [up to 1 month]

  22. The process of operation in non-ARDS group. [up to 1 month]

  23. The blood transfusion of patients during operation in ARDS group. [up to 1 month]

  24. The blood transfusion of patients during operation in non-ARDS group. [up to 1 month]

  25. The oxygenation of patients during operation in ARDS group. [up to 1 month]

  26. The oxygenation of patients during operation in non-ARDS group. [up to 1 month]

  27. The drug taken by patients after operation in ARDS group. [up to 1 month]

  28. The drug taken by patients after operation in non-ARDS group. [up to 1 month]

  29. The oxygenation of patients after operation in ARDS group. [up to 1 month]

  30. The oxygenation of patients after operation in non-ARDS group. [up to 1 month]

  31. The situation of mechanical ventilation of patients after operation in ARDS group. [up to 1 month]

  32. The situation of mechanical ventilation of patients after operation in non-ARDS group. [up to 1 month]

Secondary Outcome Measures

  1. The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital . [up to 1months]

  2. The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital . [up to 1months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases Beijing Beijing China 100029

Sponsors and Collaborators

  • Beijing Anzhen Hospital

Investigators

  • Study Chair: Guangfa Zhu, Department of Respiratory and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung and Blood Vessel Diseases

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Guangfa Zhu, chief physician, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT02759770
Other Study ID Numbers:
  • Shoufa-2016-2-1052
First Posted:
May 3, 2016
Last Update Posted:
Feb 1, 2021
Last Verified:
Dec 1, 2019

Study Results

No Results Posted as of Feb 1, 2021