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NCT00826072 Clinical Trial

Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery

Acute Lung Injury Clinical Trial

Official title:
Association Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00826072
Other study ID # PCSP-inflammation
Secondary ID
Status Completed
Phase N/A
First received January 20, 2009
Last updated May 2, 2013
Start date May 2008
Est. completion date January 2009

Study information
Verified date May 2013
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date January 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chinese Han unrelated population

- adult patients

- undergoing elective cardiac surgery with CPB

Exclusion Criteria:

- malignant tumor

- autoimmune disease, immunodeficiency or immunosuppressive therapy

- chronic renal disease (glomerular filtration rate < 60ml/(min•1.73m2)) or liver dysfunction (Child Pugh classification>A)

- COPD, tuberculosis or other chronic pulmonary diseases

- anemia with hemoglobin lower than 90mmHg

- bleeding disorders

- postoperative pericardial tamponade requiring re-operation

- postoperative low cardiac output syndrome or acute pulmonary edema after left cardiac failure.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Changhai Hospital, Second Military Medical University Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. Association between inflammatory genetic polymorphism and acute lung injury after cardiac surgery with cardiopulmonary bypass. Med Sci Monit. 2010 May;16(5):CR260-5. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Acute lung injury after cardiac surgery with cardiopulmonary bypass 24h after surgery Yes
Secondary circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE ? score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days 24h and 1 month after surgery Yes
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