AKI - Acute Kidney InjuryNCT05490394
Correlation Study of PAI-1 4G/5G Polymorphism and Postoperative AKI in Patients With Aortic Dissection
An observational study of AKI - Acute Kidney Injury and PAI-1 4G/5G Polymorphism, run by Xijing Hospital at 1 site in China.
Trial summary
To explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI in Stanford type A dissection patients undergoing open-heart repair surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury, PAI-1 4G/5G Polymorphism, Aortic Dissection
- How many people
- 283 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2022to 1 Aug 2022
- How long will I take part?
- 7 Days
- 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: For retrospective cohort: patients who previously underwent open thoracic aortic dissection correction surgery and also underwent PAI-1 4G5G polymorphism in Xijing Hospital. For prospective cohort: patients who is scheduled for open thoracic aortic dissection correction surgery (total aortic arch replacement, with or without aortic valve replacement) in Xijing Hospital.
Who may be able to join
- Stanford type A aortic dissection patient admitted to the Department of Cardiology, in Xijing Hospital
- Open thoracic aortic dissection correction (total aortic arch replacement with or without aortic valve replacement) is proposed
- Age ≥ 18 years old
- Informed consent has been signed
Who cannot join
- Cardiopulmonary bypass assisted cardiac surgery has been performed in the past three months
- Renal failure patients who have started or are receiving dialysis treatment before operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambispective Cohort Study on the Correlation Between 4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 (PAI-1) Promoter and Moderate to Severe Postoperative Acute Renal Injury in Patients With Aortic Dissection
To explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI in Stanford type A dissection patients undergoing open-heart repair surgery.
Read the detailed description
The incidence of postoperative acute kidney injury（AKI）after cardiac surgery is high, especially in patients with aortic dissection. Moderate to severe postoperative AKI (stage 2 and 3 AKI) is closely related to the poor prognosis after cardiac surgery. Patients with Stanford type A dissection who suffered from stage 2 and 3 postoperative AKI will have a 4.45 times higher mortality than that of patients without AKI. At present, there is no effective treatment for cardiac surgery associated AKI (CSA-AKI), and prevention is more important than treatment. Therefore, screening high-risk patients and implementing individualized preventive measures are of great significance for the prevention of postoperative AKI and improvement of prognosis of patients.
The previous completed RCT study in the investigators' center showed that perioperative administration of inhaled nitric oxide (NO) to patients undergoing cardiopulmonary bypass (CPB) assisted multivalve replacement surgery could significantly reduce the incidence of postoperative AKI, but the NO should be provided before CPB was started, that is, when injury began. This phenomenon implied that NO played a preventive role rather than a therapeutic role. In further studies, the investigators found that the kidney protective mechanism of NO inhalation may be related to its role on PAI-1 regulation. According to the literature, the 4G5G polymorphism in the promoter region of PAI-1 is a natural regulator of the expression level of PAI-1 in vivo. Based on these findings, the investigators reviewed some cases who underwent aortic dissection correction surgery and also PAI-1 4G5G polymorphism test in our hospital, the investigators found that 4G/4G homozygous patients had a much higher proportion of moderate to severe AKI than 4G5G heterozygous patients or 5G/5G homozygous patients. However, due to the small sample size, the differences in AKI incidence between different genotype groups were not statistical significant.
In order to further explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI, the investigators planed to expand the sample size and form a ambispective cohort study which include the retrospective cohort mentioned above and a new prospective cohort study. A total of 255 patients will be included to determine the genetic susceptibility of CSA-AKI associated with PAI-1 4G5G deletion / insertion polymorphism. All subjects included in the prospective part of this study will receive PAI-1 4G5G polymorphism test, and record whether postoperative AKI occurs and also AKI stage. There is no other intervention for patients included in this study in addition to blood collection. All medical decision-making processes in hospital will not be interfered by the research.
- Medical subject headings
- Acute Kidney Injury, Aortic Dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop postoperative moderate to severe AKI
number of participants who develop stage 2 to stage 3 AKI after the surgery
Measured: from time of the end of surgery; assessed up to 7 days
Secondary outcomes (3)
Number of participants who develop postoperative AKI
number of participants who develop all stage AKI after the surgery
Measured: from time of the end of surgery; assessed up to 7 days
In-hospital mortality
incidence of deaths happened after surgery during the hospital stay
Measured: from time of the end of surgery; assessed up to 7 days
Length of stay in hospital
duration of postoperative stay in hospital
Measured: from time of the end of surgery; assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start28 Apr 2022
- Primary completion16 Jun 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Cohort
- Time perspective
- Other
- Enrolment
- 283 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490394
- Sponsor's protocol ID
- KY20212193-F-1
- Status last verified
- Feb 2024
- First submitted
- 3 Aug 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Cohort Study on the Correlation Between 4G/5G Polymorphism of Plasminogen Activator Inhibitor-1 (PAI-1) Promoter and Moderate to Severe Postoperative Acute Renal Injury in Patients With Aortic Dissection
- ClinicalTrials.gov ID
- NCT05490394
- Acronym / sponsor ID
- KY20212193-F-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 5 Aug 2022 (actual)
- 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.
To explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI in Stanford type A dissection patients undergoing open-heart repair surgery.
Detailed description
The incidence of postoperative acute kidney injury（AKI）after cardiac surgery is high, especially in patients with aortic dissection. Moderate to severe postoperative AKI (stage 2 and 3 AKI) is closely related to the poor prognosis after cardiac surgery. Patients with Stanford type A dissection who suffered from stage 2 and 3 postoperative AKI will have a 4.45 times higher mortality than that of patients without AKI. At present, there is no effective treatment for cardiac surgery associated AKI (CSA-AKI), and prevention is more important than treatment. Therefore, screening high-risk patients and implementing individualized preventive measures are of great significance for the prevention of postoperative AKI and improvement of prognosis of patients.
The previous completed RCT study in the investigators' center showed that perioperative administration of inhaled nitric oxide (NO) to patients undergoing cardiopulmonary bypass (CPB) assisted multivalve replacement surgery could significantly reduce the incidence of postoperative AKI, but the NO should be provided before CPB was started, that is, when injury began. This phenomenon implied that NO played a preventive role rather than a therapeutic role. In further studies, the investigators found that the kidney protective mechanism of NO inhalation may be related to its role on PAI-1 regulation. According to the literature, the 4G5G polymorphism in the promoter region of PAI-1 is a natural regulator of the expression level of PAI-1 in vivo. Based on these findings, the investigators reviewed some cases who underwent aortic dissection correction surgery and also PAI-1 4G5G polymorphism test in our hospital, the investigators found that 4G/4G homozygous patients had a much higher proportion of moderate to severe AKI than 4G5G heterozygous patients or 5G/5G homozygous patients. However, due to the small sample size, the differences in AKI incidence between different genotype groups were not statistical significant.
In order to further explore the association between PAI-1 4G5G polymorphism and the risk of CSA-AKI, the investigators planed to expand the sample size and form a ambispective cohort study which include the retrospective cohort mentioned above and a new prospective cohort study. A total of 255 patients will be included to determine the genetic susceptibility of CSA-AKI associated with PAI-1 4G5G deletion / insertion polymorphism. All subjects included in the prospective part of this study will receive PAI-1 4G5G polymorphism test, and record whether postoperative AKI occurs and also AKI stage. There is no other intervention for patients included in this study in addition to blood collection. All medical decision-making processes in hospital will not be interfered by the research.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For retrospective cohort: patients who previously underwent open thoracic aortic dissection correction surgery and also underwent PAI-1 4G5G polymorphism in Xijing Hospital. For prospective cohort: patients who is scheduled for open thoracic aortic dissection correction surgery (total aortic arch replacement, with or without aortic valve replacement) in Xijing Hospital.
Key inclusion criteria (4 listed)
- Stanford type A aortic dissection patient admitted to the Department of Cardiology, in Xijing Hospital
- Open thoracic aortic dissection correction (total aortic arch replacement with or without aortic valve replacement) is proposed
- Age ≥ 18 years old
- Informed consent has been signed
Key exclusion criteria (2 listed)
- Cardiopulmonary bypass assisted cardiac surgery has been performed in the past three months
- Renal failure patients who have started or are receiving dialysis treatment before operation
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
Number of participants who develop postoperative moderate to severe AKI
Time frame: from time of the end of surgery; assessed up to 7 days
number of participants who develop stage 2 to stage 3 AKI after the surgery
3 secondary outcomes
Number of participants who develop postoperative AKI
Time frame: from time of the end of surgery; assessed up to 7 days
In-hospital mortality
Time frame: from time of the end of surgery; assessed up to 7 days
Length of stay in hospital
Time frame: from time of the end of surgery; assessed up to 7 days
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 8 Feb 2024.
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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 AKI - Acute Kidney Injury and PAI-1 4G/5G Polymorphism, run by Xijing 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 4 inclusion and 2 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 8 Feb 2024. 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?
Number of participants who develop postoperative moderate to severe AKI (time frame: from time of the end of surgery; assessed up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.