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Clinical Trials/NCT00819871
NCT00819871CompletedNot Applicable

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

Changhai Hospital1 site in 1 country105 target enrollmentStarted: May 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
1
Primary Endpoint
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass

Time Frame: 24h after cardiac surgery

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jia-feng Wang

M.D.

Changhai Hospital

Study Sites (1)

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