Risk Factors and Prediction Score of ARDS After Cardiac Surgery

Thoracic Surgery Clinical Trial

Official title:

Risk Factors and Prediction Score of ARDS After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759770
• Other study ID #: Shoufa-2016-2-1052
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: December 2019
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1333
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Risk Factors
• Thoracic Surgery

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Milot J, Perron J, Lacasse Y, Létourneau L, Cartier PC, Maltais F. Incidence and predictors of ARDS after cardiac surgery. Chest. 2001 Mar;119(3):884-8. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.		up to 12months
Primary	The number of patients of cardiac surgery in Anzhen hospital during Jan 2013 to Dec 2015.		up to 12months
Primary	The number of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.		up to 12months
Primary	The number of patients of cardiac surgery in Anzhen hospital during Jan 2017 to Dec 2017.		up to 12months
Primary	The number of diabetic patients in ARDS group.		up to 1 month
Primary	The number of diabetic patients in non-ARDS group.		up to 1 month
Primary	The number of chronic obstructive pulmonary disease patients in ARDS group.		up to 1 month
Primary	The number of chronic obstructive pulmonary disease patients in non-ARDS group.		up to 1 month
Primary	The type of operation in ARDS group.		up to 1 month
Primary	The type of operation in non-ARDS group.		up to 1 month
Primary	The body mass index in ARDS group.		up to 1 month
Primary	The body mass index in non-ARDS group.		up to 1 month
Primary	The heart function in ARDS group before operation.		up to 1 month
Primary	The heart function in non-ARDS group before operation.		up to 1 month
Primary	The oxygenation in ARDS group before operation.		up to 1 month
Primary	The oxygenation in non-ARDS group before operation.		up to 1 month
Primary	The drug taken by patients in ARDS group.		up to 1 month
Primary	The drug taken by patients in non-ARDS group.		up to 1 month
Primary	The nutrition situation of patients in ARDS group.		up to 1 month
Primary	The nutrition situation of patients in non-ARDS group.		up to 1 month
Primary	The process of operation in ARDS group.		up to 1 month
Primary	The process of operation in non-ARDS group.		up to 1 month
Primary	The blood transfusion of patients during operation in ARDS group.		up to 1 month
Primary	The blood transfusion of patients during operation in non-ARDS group.		up to 1 month
Primary	The oxygenation of patients during operation in ARDS group.		up to 1 month
Primary	The oxygenation of patients during operation in non-ARDS group.		up to 1 month
Primary	The drug taken by patients after operation in ARDS group.		up to 1 month
Primary	The drug taken by patients after operation in non-ARDS group.		up to 1 month
Primary	The oxygenation of patients after operation in ARDS group.		up to 1 month
Primary	The oxygenation of patients after operation in non-ARDS group.		up to 1 month
Primary	The situation of mechanical ventilation of patients after operation in ARDS group.		up to 1 month
Primary	The situation of mechanical ventilation of patients after operation in non-ARDS group.		up to 1 month
Secondary	The mortality of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .		up to 1months
Secondary	The morbidity of acute respiratory distress syndrome following cardiac surgery in Anzhen hospital .		up to 1months