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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
  Purpose

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
Single Nucleotide Polymorphism
Acute Lung Injury
Kidney Injury

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass [ Time Frame: 24h after cardiac surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 105
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chinese Han patients undergoing elective cardiac surgery with CPB

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819871

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

Publications:
Responsible Party: Jia-feng Wang, M.D., Changhai Hospital
ClinicalTrials.gov Identifier: NCT00819871     History of Changes
Other Study ID Numbers: PCSP-NFKB1
Study First Received: January 8, 2009
Last Updated: May 2, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 23, 2014