Clinical trial NCT06692036: Adaptive Blood Purification for the Treatment of Patients With Septic Shock
Official title: Adaptive Blood Purification for the Treatment of Patients With Septic Shock: a Multicenter, Open-label, Randomized, Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Septic Shock
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Peking University First Hospital
name: Beijing Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Air Force Military Medical University, China
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Capital Medical University
name: Beijing Boai Hospital
name: Xuanwu Hospital, Beijing
name: Beijing Jishuitan Hospital
name: Chinese PLA General Hospital
First posted: 2024-11-18
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Adult patients admitted to intensive care unit (ICU), 18 years old ≤ age ≤ 82 years old;
2. Meeting the diagnostic criteria for septic shock (Sepsis 3.0), and the onset time of septic shock ≤ 24 hours;
3. Systemic inflammatory response syndrome (SIRS) ≥ 3 points;
4. Sequential organ failure assessment (SOFA) ≥ 6 points;
5. 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.

Exclusion Criteria:

1. Patients who have received blood purification treatment within 1 week for any reason;
2. Patients with congenital or acquired immunodeficiency diseases, or those who have received organ transplantation;
3. Patients who have received immunosuppressive drugs (mycophenolate, cyclophosphamide, FK506, etc.) within 28 days before enrollment;
4. 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;
5. Patients with active bleeding (requiring blood transfusion \> 3 units in the past 24 hours);
6. Patients with malignant tumors, those who cannot remove the lesions (such as surgical patients who cannot undergo surgical treatment);
7. End-stage organ failure (end-stage pulmonary heart disease, brain death, chronic liver disease combined with hepatic encephalopathy);
8. Platelet count \< 30×10\^9/L or neutrophil count \< 0.5×10\^9/L;
9. Patients who require supportive treatment due to acute pulmonary embolism or severe congestive heart failure;
10. The mean arterial blood pressure (MAP) cannot be maintained ≥ 65 mmHg after receiving vasoactive drugs and fluid resuscitation treatment;
11. Patients who have participated or participated in another clinical study within 28 days before enrollment;
12. 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;
13. 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.

Primary outcomes:
measure: All-cause mortality at day 90
timeFrame: The follow-up time ends on the 90th day after patient enrollment.
Secondary outcomes:
measure: Declining proportion of serum cytokines
timeFrame: From enrollment to the end of first 24 hours.
measure: Improvement of SOFA score
timeFrame: The follow-up time ends on the 7th day after patient enrollment.
measure: All-cause mortality at day 30
timeFrame: The follow-up time ends on the 30th day after patient enrollment.
measure: Duration of stay
timeFrame: The follow-up time ends on the 90th day after patient enrollment.
measure: Mortality rate
timeFrame: The follow-up time ends on the 90th day after patient enrollment.
measure: Requirement of RRT
timeFrame: The follow-up time ends on the 90th day after patient enrollment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao Yang Hospital
state: Beijing
Study officials:
References: