HOPE-Sepsis: Hemoadsorption Therapy for Sepsis
ConditionSepsis and Septic Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
This is a single-center, prospective, single-arm, open-label study that will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. All participants will receive CA330 hemoadsorption in addition to standard care. Blood samples will be collected at prespecified time points before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2) to evaluate changes in IL-6 and other inflammatory biomarkers. TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes and explore their relationships with clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Hemoperfusion with CA330 Cytokine Adsorption Column
DevicePatients will receive hemoadsorption therapy using the Cytokine Adsorption Column CA330 (Jafron Biomedical Co., Ltd., Zhuhai, China). During treatment, whole blood passes through an extracorporeal hemoperfusion circuit containing the adsorption cartridge. Circulating inflammatory mediators are removed by adsorption, and the treated blood is returned directly to the patient. Plasma separation is not performed. CRRT may be administered according to routine clinical indications and is not required for study participation. Standard-of-care therapy for sepsis will be provided throughout the study according to the treating team.Each index hemoadsorption session will last approximately 2-4 hours.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Hemoadsorption ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Immediate change in plasma IL-6 concentration after hemoadsorption
The primary outcome is the immediate change in plasma IL-6 concentration from the pre-hemoadsorption baseline (T0) to immediately after completion of hemoadsorption (T1).
Time frame
Baseline before initiation of hemoadsorption (T0) and immediately after completion of hemoadsorption (T1)Secondary outcomes
1
Acute change in plasma proteomic profile after hemoadsorption
Treatment-associated changes in plasma protein expression profiles from T0 to T1, analyzed using TMT-based quantitative proteomics.
Time frame
Baseline before initiation of hemoadsorption (T0) and immediately after completion of hemoadsorption (T1)2
Changes in inflammatory markers
Changes in TNF-α, IL-8, and other prespecified inflammatory biomarkers across T0, T1, and T2.
Time frame
Baseline before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after treatment (T2)3
Change in SOFA score
Change in Sequential Organ Failure Assessment (SOFA) score
Time frame
Baseline, 24 hours, 48 hours, and 7 days after treatment4
28 day all-cause mortality
Death from any cause by Day 28 after enrollment.
Time frame
Up to 28 days.Other outcomes
1
Treatment-related adverse events
Frequency and severity of adverse events related to hemoperfusion therapy, including bleeding events, infection, and hypotension, graded according to CTCAE v5.0 criteria.
Time frame
During treatment and through Day 28 after enrollment (or until hospital discharge, whichever occurs first).Sponsors and contacts
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Source ClinicalTrials.gov
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