Adaptive Blood Purification for the Treatment of Patients With Septic Shock: a Multicenter, Open-label, Randomized, Parallel Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- All-cause mortality at day 90
研究概览
简要总结
There is a lack of evidence in the efficacy of extracorporeal blood purification (EBP) to reduce the mortality rate in septic shock. We have designed the EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit. In this multicenter, open-label, randomized controlled trial, We are recruiting a total of 276 patients with septic shock. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either the control group or the intervention group. Patients in the control group will receive standard care according to the Surviving Sepsis Guidelines. Patients in the intervention group will receive two 6-hour sessions of ABP treatment within 24 hours of enrollment, based on standard care. ABP is a novel, adaptive EBP strategy proposed by our research team, specifically, for patients with septic shock do not require renal replacement therapy (RRT), plasma filtration-adsorption (PFAD) will be used alone, and for patients with septic shock and acute kidney injury meeting RRT indications, a combination of PFAD-RRT will be employed. The primary endpoint of this study is all-cause mortality at 90 days after enrollment. Secondary endpoints of the study include the declining proportion of serum cytokines such as TNF-α, IL-4, IL-6, IL-8, IL-10, and HMGB1 within 24 hours after enrollment. Additionally, the study will evaluate the improvement of Sequential Organ Failure Assessment score on day 7 post-enrollment, as well as the 30-day mortality rate.
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 (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to intensive care unit (ICU), 18 years old ≤ age ≤ 82 years old;
- •Meeting the diagnostic criteria for septic shock (Sepsis 3.0), and the onset time of septic shock ≤ 24 hours;
- •Systemic inflammatory response syndrome (SIRS) ≥ 3 points;
- •Sequential organ failure assessment (SOFA) ≥ 6 points;
- •Voluntarily sign the informed consent form before the trial, and agree to participate in all visits, examinations, and treatments according to the requirements of the research plan.
排除标准
- •Patients who have received blood purification treatment within 1 week for any reason;
- •Patients with congenital or acquired immunodeficiency diseases, or those who have received organ transplantation;
- •Patients who have received immunosuppressive drugs (mycophenolate, cyclophosphamide, FK506, etc.) within 28 days before enrollment;
- •Patients who received continuous treatment (≥ 3 days) with more than 10 mg/day of prednisolone (or other hormones at equivalent doses) within 28 days before enrollment;
- •Patients with active bleeding (requiring blood transfusion > 3 units in the past 24 hours);
- •Patients with malignant tumors, those who cannot remove the lesions (such as surgical patients who cannot undergo surgical treatment);
- •End-stage organ failure (end-stage pulmonary heart disease, brain death, chronic liver disease combined with hepatic encephalopathy);
- •Platelet count < 30×10^9/L or neutrophil count < 0.5×10^9/L;
- •Patients who require supportive treatment due to acute pulmonary embolism or severe congestive heart failure;
- •The mean arterial blood pressure (MAP) cannot be maintained ≥ 65 mmHg after receiving vasoactive drugs and fluid resuscitation treatment;
- •Patients who have participated or participated in another clinical study within 28 days before enrollment;
- •Patients who are allergic to extracorporeal circulation materials, perfusion device materials or have a history of other severe allergies, or those who have heparin-associated thrombocytopenia;
- •Patients who are inappropriate for participating, such as pregnant or lactating women, patients with severe mental and neurological diseases, and those with a history of alcoholism that cannot be terminated.
研究组 & 干预措施
Control group (standard treatment)
Patients in the control group received standard treatment by the "Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021".
Intervention group (standard treatment + ABP)
Intervention Type: Patients in the intervention group, based on standard treatment, received two 6-hour adaptive blood purification (ABP) treatments within 24 hours after enrollment, that is, patients did not indicate renal replacement therapy (RRT), only plasma filtration-adsorption (PFAD) therapy is used to adsorb inflammatory factors; for patients with acute kidney injury (AKI) and meeting RRT indications, PFAD-RRT treatment is used.
干预措施: Adaptive Blood Purification (ABP) (Other)
结局指标
主要结局
All-cause mortality at day 90
时间窗: The follow-up time ends on the 90th day after patient enrollment.
The primary endpoint is all-cause mortality at day 90 after enrollment.
次要结局
- Declining proportion of serum cytokines(From enrollment to the end of first 24 hours.)
- Improvement of SOFA score(The follow-up time ends on the 7th day after patient enrollment.)
- All-cause mortality at day 30(The follow-up time ends on the 30th day after patient enrollment.)
- Duration of stay(The follow-up time ends on the 90th day after patient enrollment.)
- Mortality rate(The follow-up time ends on the 90th day after patient enrollment.)
- Requirement of RRT(The follow-up time ends on the 90th day after patient enrollment.)