Acute Lung Injury Clinical Trial
Official title:
Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
Verified date | May 2013 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Observational |
NFKB1 -94ins/del polymorphism has been reported to be associated with reduced promoter activity of NFKB1 and several clinical diseases, but the clinical results cannot always be replicated. Besides, mutate allele is associated with alleviated inflammation in ulcerative colitis and some tumors, but aggravated inflammation in ARDS. The clinical value of this polymorphism remains controversial. This study was performed to investigate the association of NFKB1 -94ins/delATTG polymorphism with lung and/or kidney injury after cardiac surgery with CPB.
Status | Completed |
Enrollment | 105 |
Est. completion date | December 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chinese Han unrelated population - 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. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Changhai Hospital, Second Military Medical University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
China,
Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. NFKB1-94ins/del polymorphism is not associated with lung injury after cardiopulmonary bypass. Anaesthesia. 2010 Feb;65(2):158-62. doi: 10.1111/j.1365-2044.2009.06186.x. Epub 2009 Nov 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass | 24h after cardiac surgery | Yes | |
Secondary | circulating level of CRP, TNF-alpha, IL-10; APACHE ? score; duration of ICU stay and hospitalization; death in 28 days | one month after cardiac surgery | Yes |
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