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

History of Changes

Tracking Information
First Received Date ^ICMJE	January 8, 2009
Last Updated Date	May 2, 2013
Start Date ^ICMJE	May 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 8, 2009)	lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass [ Time Frame: 24h after cardiac surgery ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00819871 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 8, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
Official Title ^ICMJE	Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: 3ml blood before surgery, after surgery and 24h after surgery respectively
Sampling Method	Probability Sample
Study Population	Chinese Han patients undergoing elective cardiac surgery with CPB
Condition ^ICMJE	Single Nucleotide Polymorphism Acute Lung Injury Kidney Injury
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	105
Completion Date	December 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00819871
Other Study ID Numbers ^ICMJE	PCSP-NFKB1
Has Data Monitoring Committee	Yes
Responsible Party	Jia-feng Wang, Changhai Hospital
Study Sponsor ^ICMJE	Changhai Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Changhai Hospital
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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