Acute Lung InjuryNCT00826072
Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery
An observational study of Acute Lung Injury, run by Changhai Hospital at 1 site in China.
Trial summary
Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Jan 2009
- 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: Unrelated Chinese Han patients undergoing elective cardiac surgery with CPB
Who may be able to join
- Chinese Han unrelated population
- adult patients
- 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 Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass
Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.
- Conditions
- Acute Lung Injury
- Keywords
- Single Nucleotide Polymorphism, cardiopulmonary bypass, cardiac surgery
- 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 |
|---|---|---|
| ALI | patients with acute lung injury at 24h after cardiac surgery | |
| Control | patients without acute lung injury 24h after cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute lung injury after cardiac surgery with cardiopulmonary bypass
Measured: 24h after surgery
Secondary outcomes (1)
circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE Ⅱ score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days
Measured: 24h and 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionJan 2009
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 Acute Lung InjuryStudies 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
- 107 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
- NCT00826072
- Sponsor's protocol ID
- PCSP-inflammation
- Status last verified
- May 2013
- First submitted
- 20 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. Association between inflammatory genetic polymorphism and acute lung injury after cardiac surgery with cardiopulmonary bypass. Med Sci Monit. 2010 May;16(5):CR260-5.
PubMed 20424554
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 Study of Inflammatory Genetic Polymorphism and Acute Lung Injury After Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00826072
- Acronym / sponsor ID
- PCSP-inflammation
- Conditions
- Acute Lung Injury
- Keywords
- Single Nucleotide Polymorphism, cardiopulmonary bypass, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 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.
Acute lung injury is a common complication of cardiac surgery with cardiopulmonary bypass, and it is significantly related to prolonged postoperative recovery, hospital stays and medical cost. Currently available predictors of acute lung injury after cardiac surgery are still limited within clinical data. Several genetic polymorphism of inflammatory mediators have been reported to be associated with severity of sepsis and ARDS, but the association of these inflammatory polymorphism and acute lung injury after cardiac surgery has never been reported. This study is performed to investigate the association of genetic polymorphisms including TNF -308A/G, IL-10 -1082A/G and IL-6 -572C/G and postoperative lung injury.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALI | – | –patients with acute lung injury at 24h after cardiac surgery |
| Control | – | –patients without acute lung injury 24h after cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unrelated Chinese Han patients undergoing elective cardiac surgery with CPB
Key inclusion criteria (3 listed)
- Chinese Han unrelated population
- adult patients
- 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
Acute lung injury after cardiac surgery with cardiopulmonary bypass
Time frame: 24h after surgery
1 secondary outcome
circulating level of CRP, TNF-alpha, IL-10, IL-6; APACHE Ⅱ score; postoperative kidney injury, duration of ventilation, ICU stay and hospitalization; death in 28 days
Time frame: 24h and 1 month after 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 20424554Wang JF, Bian JJ, Wan XJ, Zhu KM, Sun ZZ, Lu AD. Association between inflammatory genetic polymorphism and acute lung injury after cardiac surgery with cardiopulmonary bypass. Med Sci Monit. 2010 May;16(5):CR260-5.
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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 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 3 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?
Acute lung injury after cardiac surgery with cardiopulmonary bypass (time frame: 24h after 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 NCT00826072, 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.