Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05490394 |
| Other study ID # |
KY20212193-F-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2022 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Xijing Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
