- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819871
Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
May 2, 2013 updated by: Jia-feng Wang, Changhai Hospital
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shanghai, China, 200433
- Changhai Hospital, Second Military Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Chinese Han patients undergoing elective cardiac surgery with CPB
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
PLI
patients with postoperative lung injury
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without PLI
patients without postoperative lung injury
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PLI/PKI
patients with at least one organ injury of lung or kidney after surgery
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without PLI/PKI
patients without lung or kidney injury after surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass
Time Frame: 24h after cardiac surgery
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24h after cardiac surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
one month after cardiac surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
January 8, 2009
First Submitted That Met QC Criteria
January 8, 2009
First Posted (Estimate)
January 9, 2009
Study Record Updates
Last Update Posted (Estimate)
May 3, 2013
Last Update Submitted That Met QC Criteria
May 2, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCSP-NFKB1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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