Single Nucleotide PolymorphismNCT00819871
Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
An observational study of Single Nucleotide Polymorphism and Acute Lung Injury, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Nucleotide Polymorphism, Acute Lung Injury, Kidney Injury
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Han patients undergoing elective cardiac surgery with CPB
Who may be able to join
- Chinese Han unrelated population
- undergoing elective cardiac surgery with CPB
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: 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.
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass
Measured: 24h after cardiac surgery
Secondary outcomes (1)
circulating level of CRP, TNF-alpha, IL-10; APACHE Ⅱ score; duration of ICU stay and hospitalization; death in 28 days
Measured: one month after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single Nucleotide PolymorphismStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-feng Wang, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819871
- Sponsor's protocol ID
- PCSP-NFKB1
- Status last verified
- May 2013
- First submitted
- 8 Jan 2009
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 19995347
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of NFKB1 -94 Polymorphism With Lung and/or Kidney Injury After Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00819871
- Acronym / sponsor ID
- PCSP-NFKB1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Han patients undergoing elective cardiac surgery with CPB
Key inclusion criteria (2 listed)
- Chinese Han unrelated population
- undergoing elective cardiac surgery with CPB
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass
Time frame: 24h after cardiac surgery
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Results publication: PubMed 19995347Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Nucleotide Polymorphism and Acute Lung Injury, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung injury and/or kidney injury after cardiac surgery with cardiopulmonary bypass (time frame: 24h after cardiac surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.