Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
1 other identifier
observational
105
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedMay 3, 2013
May 1, 2013
5 months
January 8, 2009
May 2, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass
24h after cardiac surgery
Secondary Outcomes (1)
circulating level of CRP, TNF-alpha, IL-10; APACHE Ⅱ score; duration of ICU stay and hospitalization; death in 28 days
one month after cardiac surgery
Study Arms (4)
PLI
patients with postoperative lung injury
without PLI
patients without postoperative lung injury
PLI/PKI
patients with at least one organ injury of lung or kidney after surgery
without PLI/PKI
patients without lung or kidney injury after surgery
Eligibility Criteria
Chinese Han patients undergoing elective cardiac surgery with CPB
You may qualify if:
- Chinese Han unrelated population
- undergoing elective cardiac surgery with CPB
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, 200433, China
Related 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.
PMID: 19995347RESULT
Biospecimen
3ml blood before surgery, after surgery and 24h after surgery respectively
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
May 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
May 3, 2013
Record last verified: 2013-05