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Septic ShockNCT06692036

Adaptive Blood Purification for the Treatment of Patients With Septic Shock

A study testing Adaptive Blood Purification (ABP) in people with Septic Shock, run by Beijing Chao Yang Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 82 years
Conditions the study is for
Septic Shock
What is being tested?
Adaptive Blood Purification (ABP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
276 participants
Where
1 siteChina
Study dates
1 Jan 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Beijing Chao Yang Hospital

    Beijing, Beijing Municipality, 100020

Other trials in China

About this study

Official title: Adaptive Blood Purification for the Treatment of Patients With Septic Shock: a Multicenter, Open-label, Randomized, Parallel Controlled Study

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.

Conditions
Septic Shock
Being tested
Adaptive Blood Purification (ABP)
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive Blood Purification (ABP)Other

    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 coupled 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.

Study groups in NCT06692036
Study groupRoleWhat they receive
Control group (standard treatment)No interventionPatients 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)ExperimentalIntervention 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.
Receives: Other: Adaptive Blood Purification (ABP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality at day 90

    The primary endpoint is all-cause mortality at day 90 after enrollment.

    Measured: The follow-up time ends on the 90th day after patient enrollment.

Secondary outcomes (6)

  1. Declining proportion of serum cytokines

    The declining proportion (DP %) of serum cytokines such as TNF-α, IL-4, IL-6, IL-8, IL-10, and HMGB1 within 24 hours after enrollment (DP % = (CytokineH0 - CytokineH24)/CytokineH0 ), H0 is the serum cytokine level measured at the time of enrollment; H24 is the serum cytokine level measured at 24h after enrollment).

    Measured: From enrollment to the end of first 24 hours.

  2. Improvement of SOFA score

    Improvement of sequential organ failure assessment score (SOFA) on the 7th day after enrollment.

    Measured: The follow-up time ends on the 7th day after patient enrollment.

  3. All-cause mortality at day 30

    30-day all-cause mortality rate after enrollment.

    Measured: The follow-up time ends on the 30th day after patient enrollment.

  4. Duration of stay

    The duration of stay in the intensive care unit and in the hospital.

    Measured: The follow-up time ends on the 90th day after patient enrollment.

  5. Mortality rate

    The mortality rate within the intensive care unit and the hospital.

    Measured: The follow-up time ends on the 90th day after patient enrollment.

  6. Requirement of RRT

    The requirement of renal replacement therapy (RRT) at both day 30 and day 90 after enrollment.

    Measured: The follow-up time ends on the 90th day after patient enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
276 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692036
Sponsor's protocol ID
Capital'sFunds2024-1-2031
Status last verified
Jan 2026
First submitted
22 Oct 2024
Last updated
29 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: EABPSS (Efficacy of Adaptive Blood Purification for Septic Shock) study aims to confirm whether adaptive blood purification (ABP) intervention could confer a clinical benefit.

Publications

  • Jia H, Li X, Zheng Y, Cui N, Ronco C, Li W. Efficacy of Adaptive Blood Purification for Septic Shock (EABPSS): protocol for a randomised, multicentre, parallel controlled study. BMJ Open. 2025 Oct 20;15(10):e107311. doi: 10.1136/bmjopen-2025-107311.

    PubMed 41120165

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive Blood Purification (ABP) in people with Septic Shock, run by Beijing Chao Yang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality at day 90 (time frame: The follow-up time ends on the 90th day after patient enrollment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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