Correlation Study of PAI-1 4G/5G Polymorphism and Postoperative AKI in Patients With Aortic Dissection

February 7, 2024 updated by: Chong Lei, MD & phD, Xijing Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

283

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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from time of the end of surgery; assessed up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who develop postoperative AKI
Time Frame: from time of the end of surgery; assessed up to 7 days
number of participants who develop all stage AKI after the surgery
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
incidence of deaths happened after surgery during the hospital stay
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
duration of postoperative stay in hospital
from time of the end of surgery; assessed up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

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 (Actual)

April 28, 2022

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

August 3, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20212193-F-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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