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Effects of Intraoperative Hemoperfusion on Acute Kidney Injury After Aortic Dissection (EIHPOAKIAD)

Primary Purpose

Aortic Dissection

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraoperative Hemoperfusion
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Dissection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged from 18 to 75 years old;
  • Patients had aortic dissection type A with onset within 7 days.

Exclusion Criteria:

  • Preoperative CTA suggests unilateral or bilateral renal artery false lumen blood supply;
  • Past history of renal insufficiency;
  • Difficulty in hemostasis during operation due to taking anticoagulant and antiplatelet drugs for various reasons before operation, and the CPB time exceeds 4 hours;
  • Severe organ perfusion before surgery, such as lower extremity ischemia or preoperative coma;
  • BMI>40 Kg/m^2 or pregnancy status.

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hemoperfusion and CPB and DHCA surgery

traditional CPB and DHCA surgery

Arm Description

The experimental group was treated with hemoperfusion simultaneously with CPB and DHCA.

The control group was treated with intraoperative CPB and DHCA surgery.

Outcomes

Primary Outcome Measures

Incidence of acute kidney injury
The serum creatinine of the patients was collected, combined with KDIGO criteria to judge the occurrence and staging of acute kidney injury.

Secondary Outcome Measures

the expression level of serum CIRP
The expression level of serum CIRP in patients after operation.
the expression level of serum inflammatory factor
Changes in the expression levels of serum inflammatory factors within 7 days after surgery;

Full Information

First Posted
April 10, 2022
Last Updated
April 10, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05331495
Brief Title
Effects of Intraoperative Hemoperfusion on Acute Kidney Injury After Aortic Dissection
Acronym
EIHPOAKIAD
Official Title
Prospective Study on the Effect of Intraoperative Hemoperfusion on CIRP Expression and Acute Kidney Injury After Aortic Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 20, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute kidney injury (AKI) is a common and serious complication after aortic dissection (AD), and it is closely related to the inflammatory response associated with cardiopulmonary bypass. Hemoperfusion can reduce the level of systemic inflammatory response effectively in patients with sepsis. Some studies have tried to apply hemoperfusion to cardiopulmonary bypass surgery, and put forward the concept of "absorptive cardiopulmonary bypass", but there are few related research reports. The use of hemoperfusion during cardiopulmonary bypass can reduce the level of systemic inflammatory response, thereby reducing the risk of postoperative AKI and improving the prognosis of patients. The Cardiovascular Surgery Department of the First Affiliated Hospital of Jiaotong University is one of the first demonstration units of "adsorption-type cardiopulmonary bypass" in China. Our previous retrospective analysis shown that intraoperative hemoperfusion can effectively reduce the occurrence of postoperative AKI in patients with AD, compared with traditional cardiopulmonary bypass. In addition, previous studies have found that the increased expression of CIRP after cardiopulmonary bypass can aggravate the oxidative stress and mitochondrial dynamics disorder in renal tubular epithelial cells, thereby inducing AKI. This project is a single-center randomized controlled study. It intends to investigate whether the application of hemoperfusion during cardiopulmonary bypass in patients with AD to reduce the level of systemic inflammatory response can reduce the incidence of postoperative AKI and improve the patient's discharge outcome. At the same time, exploratory studies were conducted to investigate whether hemoperfusion could effectively reduce the expression level of CIRP in the circulation. The successful implementation of this study can provide effective intervention methods and related theoretical basis for reducing the risk of AKI after aortic dissection.
Detailed Description
The aim of this study is to explore the effect of hemoperfusion during cardiopulmonary bypass (CPB) on the expression of CIRP in serum after aortic dissection and the incidence of postoperative acute kidney injury (AKI). The subjects of the study are patients with aortic dissection of Stanford type A (AAD) who were treated in the First Affiliated Hospital of Xi'an Jiaotong University and required surgical treatment in cardiovascular surgery. The main types of surgery are ascending aortic replacement or Bentall and Sun's surgery, and all of them undergo deep hypothermic circulatory arrest (DHCA). The general process of this study is that the patients with AAD treated in our hospital who needed surgical treatment were randomly divided into two groups according to the inclusion and exclusion criteria. The control group was treated with intraoperative CPB and DHCA, and the experimental group was treated with hemoperfusion simultaneously with CPB and DHCA. By detecting the expression level of CIRP in the postoperative serum and the incidence of AKI within 7 days after the operation, the prognosis difference between the two groups was analyzed. Follow-up content: Collect preoperative clinical data, that is, general information of patients: hospital number, name, gender, age, BMI, smoking history, history of hypertension, diabetes, myocardial infarction and angina pectoris, history of chronic obstructive pulmonary disease, peripheral vascular disease, and brain vascular accident, cardiac function classification, cardiac ultrasonography EF value, preoperative creatinine level, eGFR, cystatin C level, hemoglobin Hct, preoperative CTA results whether the lesion involved renal artery and whether preoperative poor organ perfusion performance. The main evaluation index of postoperative follow-up was whether AKI occurred within 7 days after surgery. The diagnostic criteria for AKI were based on the KDIGO diagnostic criteria. The secondary evaluation criteria were the expression level of serum CIRP 24 hours after surgery, and the changes in the expression level of serum inflammatory factors within 7 days after surgery, and the postoperative survival rate, ventilator assistance time, ICU hospitalization time, postoperative hospitalization time, infection and SOFA score. The criteria for the termination or withdrawal of the study subjects were that the family members of the patients gave up the follow-up treatment due to personal reasons (economic reasons, etc.), or coronary artery bypass grafting was required due to lesions during the operation, or serious complications such as poor cardiac resuscitation and difficulty in hemostasis occurred or ECMO assistance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemoperfusion and CPB and DHCA surgery
Arm Type
Experimental
Arm Description
The experimental group was treated with hemoperfusion simultaneously with CPB and DHCA.
Arm Title
traditional CPB and DHCA surgery
Arm Type
No Intervention
Arm Description
The control group was treated with intraoperative CPB and DHCA surgery.
Intervention Type
Device
Intervention Name(s)
Intraoperative Hemoperfusion
Intervention Description
During the operation, the hemoperfusion device and the membrane oxygenator of the extracorporeal circulation device were operated in parallel.
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury
Description
The serum creatinine of the patients was collected, combined with KDIGO criteria to judge the occurrence and staging of acute kidney injury.
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
the expression level of serum CIRP
Description
The expression level of serum CIRP in patients after operation.
Time Frame
24 hours after surgery
Title
the expression level of serum inflammatory factor
Description
Changes in the expression levels of serum inflammatory factors within 7 days after surgery;
Time Frame
7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged from 18 to 75 years old; Patients had aortic dissection type A with onset within 7 days. Exclusion Criteria: Preoperative CTA suggests unilateral or bilateral renal artery false lumen blood supply; Past history of renal insufficiency; Difficulty in hemostasis during operation due to taking anticoagulant and antiplatelet drugs for various reasons before operation, and the CPB time exceeds 4 hours; Severe organ perfusion before surgery, such as lower extremity ischemia or preoperative coma; BMI>40 Kg/m^2 or pregnancy status.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinglong Zheng, PhD
Phone
0086-029-85323866
Email
zhengxinglongmay@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Ma, PhD
Phone
0086-029-85323866
Email
mataodr@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinglong Zheng, PhD
Organizational Affiliation
First Affiliated Hospital of Xian Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinglong Zheng, PhD
Phone
0086-029-85323866
Email
zhengxinglongmay@163.com

12. IPD Sharing Statement

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Effects of Intraoperative Hemoperfusion on Acute Kidney Injury After Aortic Dissection

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