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

Sponsored by:	Changhai Hospital
Information provided by:	Changhai Hospital
ClinicalTrials.gov Identifier:	NCT00819871

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

MedlinePlus related topics: Heart Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass

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

Biospecimen Description:

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

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

Responsible Party:	Department of Anesthesiology and Intensive Care Unit, Changhai Hospital
Study ID Numbers:	PCSP-NFKB1
Study First Received:	January 8, 2009
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00819871
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

ClinicalTrials.gov processed this record on January 16, 2009