An interventional study of Hemoperfusion with CA330 Cytokine Adsorption Column in Sepsis and Septic Shock, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
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.
Sepsis is a life-threatening syndrome caused by a dysregulated host response to infection and is associated with substantial morbidity and mortality in critically ill patients. Elevated circulating inflammatory mediators, including interleukin-6 (IL-6), are associated with disease severity and adverse clinical outcomes. Hemoadsorption is an extracorporeal blood purification approach in which whole blood passes through an adsorption cartridge to reduce circulating inflammatory mediators. Unlike plasma adsorption techniques, plasma separation is not required.
This single-center, prospective, single-arm study will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. After screening and written informed consent, eligible participants will undergo baseline clinical assessment followed by hemoadsorption therapy using the CA330 Cytokine Adsorption Column. Blood samples will be collected at three prespecified time points: baseline before initiation of hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2). IL-6 and other inflammatory biomarkers will be assessed at T0, T1, and T2. Exploratory TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes.
Continuous renal replacement therapy (CRRT) and other organ-supportive treatments will be initiated according to routine clinical indications and standard ICU practice. CRRT is not required for study eligibility and, when used, will be recorded as concomitant therapy. Other treatments, including antimicrobial therapy, fluid resuscitation, vasopressors, mechanical ventilation, and additional organ support, will be provided according to the patient's clinical condition.
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). Secondary outcomes include the sustained change in IL-6 at approximately 24 hours (T2), changes in plasma proteomic profiles and other inflammatory biomarkers, Sequential Organ Failure Assessment (SOFA) scores, hemodynamic parameters, renal replacement therapy use, ventilator-free days, 28-day and 90-day all-cause mortality, ICU mortality, ICU length of stay, and hospital length of stay. Safety events associated with hemoadsorption, including bleeding, infection, and hypotension, will also be recorded.
The planned sample size is 30 participants. The sample size was determined based on an expected 30% within-participant reduction in IL-6 after hemoadsorption, with a two-sided alpha of 0.05 and statistical power of 80%, while allowing for participant dropout, specimen quality issues, and variability in IL-6 levels among patients with sepsis.
Within-participant changes in continuous variables will be assessed using paired statistical methods, including paired t-tests or Wilcoxon signed-rank tests, as appropriate. Plasma proteomic data will be analyzed to identify treatment-associated protein changes and associated biological pathways using pathway enrichment and protein-interaction analyses. Relationships between proteomic changes and clinical parameters will be explored using correlation analyses.
Participants will be followed during the index hospitalization and through Day 90 after enrollment. All-cause mortality will be assessed at Day 28 and Day 90.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 30 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥18 years. Sepsis (Sepsis-3): Diagnosis of sepsis according to Sepsis-3 criteria. Blood IL-6 >100 pg/mL, Expected ICU stay >48 hours. Informed consent obtained from the patient or legally authorized representative
Exclusion Criteria:
Immunosuppressed state, such as receiving immunosuppressive therapy or HIV infection.
Severe coagulation dysfunction, including platelet count \<50 × 10⁹/L or significantly prolonged PT/APTT.
Pre-existing chronic kidney disease or end-stage renal disease. Pregnancy or lactation. Refusal to participate in the study.
Participants will receive CA330 hemoadsorption in addition to standard care for sepsis. Blood samples will be collected at T0 (before hemoadsorption), T1 (immediately after completion of hemoadsorption), and T2 (24 ±2 hours after treatment) for biomarker assessment. Plasma proteomics will be performed using samples collected at T0 and T1.
Device: Hemoperfusion with CA330 Cytokine Adsorption Column
Patients 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.
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)
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)
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)
Change in SOFA score
Change in Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline, 24 hours, 48 hours, and 7 days after treatment
28 day all-cause mortality
Death from any cause by Day 28 after enrollment.
Time frame: Up to 28 days.
ICU mortality (death before ICU discharge)
Death occurring before ICU discharge during the ICU stay in which the participant is enrolled.
Time frame: From ICU admission to ICU discharge or death, up to 90 days.
Length of ICU stay
Number of days from ICU admission to ICU discharge.
Time frame: From ICU admission to ICU discharge, up to 90 days.
Length of hospital stay
Number of days from hospital admission to hospital discharge.
Time frame: From hospital admission to hospital discharge, up to 90 days.
Hemodynamic stability
Changes in mean arterial pressure (MAP) and vasopressor requirements
Time frame: Baseline, 24 hours, 48 hours after treatment
Renal replacement therapy use
Requirement for and duration of renal replacement therapy during the index hospitalization.
Time frame: During the index hospitalization, up to 30 days
Ventilator-free days to Day 28
Days free from mechanical ventilation within 28 days.
Time frame: Up to 28 days
Sustained change in plasma IL-6 concentration at 24 hours
Change in plasma IL-6 concentration from T0 to T2 to assess persistence or rebound of the early IL-6 response after hemoadsorption.
Time frame: Baseline before hemoadsorption (T0) and approximately 24 hours after treatment (T2)
90-day all-cause mortality
Death from any cause by Day 90 after enrollment.
Time frame: Up to 90 days
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).
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication may be made available upon reasonable request to the principal investigator, subject to institutional policies and applicable ethics requirements.
Supporting information: Study protocol
No publications or documents are linked to this record.
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Shanghai Zhongshan Hospital