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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00819871
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
Jia-feng Wang, Changhai Hospital

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.

Condition or disease
Single Nucleotide Polymorphism Acute Lung Injury Kidney Injury

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Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

patients with postoperative lung injury
without PLI
patients without postoperative lung injury
patients with at least one organ injury of lung or kidney after surgery
without PLI/PKI
patients without lung or kidney injury after surgery

Primary Outcome Measures :
  1. lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass [ Time Frame: 24h after cardiac surgery ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
3ml blood before surgery, after surgery and 24h after surgery respectively

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese Han patients undergoing elective cardiac surgery with CPB

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00819871

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Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital

Publications of Results:
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Responsible Party: Jia-feng Wang, M.D., Changhai Hospital Identifier: NCT00819871    
Other Study ID Numbers: PCSP-NFKB1
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders