Effects of Intraoperative Hemoperfusion on Acute Kidney Injury After Aortic Dissection

NCT05331495 | Unknown

• 1 other identifier: XJTU1AF2021CRF-029
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days after surgery

Secondary Outcomes (2)

• the expression level of serum CIRP

  24 hours after surgery

• the expression level of serum inflammatory factor

  7 days after surgery

Study Arms (2)

Hemoperfusion and CPB and DHCA surgery

EXPERIMENTAL

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

Device: Intraoperative Hemoperfusion

traditional CPB and DHCA surgery

NO INTERVENTION

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

Interventions

Intraoperative Hemoperfusion DEVICE

During the operation, the hemoperfusion device and the membrane oxygenator of the extracorporeal circulation device were operated in parallel.

Hemoperfusion and CPB and DHCA surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Xinglong Zheng, PhD

  First Affiliated Hospital of Xian Jiaotong University

  STUDY CHAIR

Central Study Contacts

Xinglong Zheng, PhD

CONTACT

0086-029-85323866; zhengxinglongmay@163.com

Tao Ma, PhD

CONTACT

0086-029-85323866; mataodr@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 15, 2022
• Study Start: April 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2022

Record last verified: 2021-04

Locations

CN (1)