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临床试验/NCT05331495
NCT05331495Unknown不适用

Prospective Study on the Effect of Intraoperative Hemoperfusion on CIRP Expression and Acute Kidney Injury After Aortic Dissection

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2022年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
206
试验地点
1
主要终点
Incidence of acute kidney injury

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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.

研究组 & 干预措施

Hemoperfusion and CPB and DHCA surgery

Experimental

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

干预措施: Intraoperative Hemoperfusion (Device)

traditional CPB and DHCA surgery

No Intervention

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

结局指标

主要结局

Incidence of acute kidney injury

时间窗: 7 days after surgery

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

次要结局

  • the expression level of serum inflammatory factor(7 days after surgery)
  • the expression level of serum CIRP(24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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