Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jia-feng Wang, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00819871
First received: January 8, 2009
Last updated: May 2, 2013
Last verified: May 2013

January 8, 2009
May 2, 2013
May 2008
October 2008   (final data collection date for primary outcome measure)
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass [ Time Frame: 24h after cardiac surgery ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00819871 on ClinicalTrials.gov Archive Site
circulating level of CRP, TNF-alpha, IL-10; APACHE Ⅱ score; duration of ICU stay and hospitalization; death in 28 days [ Time Frame: one month after cardiac surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

3ml blood before surgery, after surgery and 24h after surgery respectively

Probability Sample

Chinese Han patients undergoing elective cardiac surgery with CPB

  • Single Nucleotide Polymorphism
  • Acute Lung Injury
  • Kidney Injury
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00819871
PCSP-NFKB1
Yes
Jia-feng Wang, Changhai Hospital
Changhai Hospital
Not Provided
Not Provided
Changhai Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP