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NCT00819871 Clinical Trial

Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery

Acute Lung Injury Clinical Trial

Official title:
Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00819871
Other study ID # PCSP-NFKB1
Secondary ID
Status Completed
Phase N/A
First received January 8, 2009
Last updated May 2, 2013
Start date May 2008
Est. completion date December 2008

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

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.

Recruitment information / eligibility
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.

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. 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

Outcome
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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