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Adaptive Blood Purification for the Treatment of Patients With Septic Shock

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Minor Collaborators revised (6)v7
  2. Minor Collaborators: 11 to 6v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Start date: Jan 1, 2024 to Jan 1, 2025v4 Show 4 more changesShow less
    • Eligibility criteria shortened, about 42 words
    • Secondary endpoints: 3 to 6
    • Primary endpoint revised
    • Collaborators: 10 to 11
  5. Minor Study Identification, Study Status, Oversight, Study Description, Eligibilityv3
  6. Minor Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 1 of 3 entries
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06692036
Lead Sponsor Beijing Chao Yang Hospital
Collaborators: China-Japan Friendship Hospital, Peking University First Hospital, Beijing Hospital, Beijing Jishuitan Hospital, Chinese PLA General Hospital, Air Force Medical Center of PLA
Conditions
(from sponsor)
Septic Shock
Related terms Shock, Septic
Enrollment 276 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov