NCT07711197

Brief Summary

This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 30, 2026

Last Update Submit

July 14, 2026

Conditions

Septic Shock

Keywords

sepsisseptic shockhemoadsorptionCytoSorbendothelial dysfunctionsyndecan-1vasoplegia

Outcome Measures

Primary Outcomes (1)

  • Changes in Syndecan-1 serum levels

    Serum Syndecan-1, a marker of endothelial glycocalyx injury, will be measured in arterial blood samples. The outcome is the log-scale change from baseline to the T24 post-baseline Syndecan-1 value in ng/mL. If the T24 value is missing, the value will be considered missing. Negative values indicate a decrease from baseline. Syndecan-1 values will be analysed on the natural logarithmic scale due to expected right skew.

    Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)

Secondary Outcomes (24)

  • Change in Sequential Organ Failure Assessment (SOFA)-2 score

    Baseline (T0), 24 hours, and then daily up to 5 days.

  • Change from baseline in arterial blood concentrations of endothelial and glycocalyx-specific markers (Glypican-1, Heparan-sulfate, sICAM-1, sVCAM-1, soluble E-selectin, soluble P-selectin)

    Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.

  • Change from baseline in arterial blood concentrations of endothelial markers (MCP-1, VEGF)

    Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.

  • Change from baseline in quantification cycle values of selected microRNAs associated with endothelial function, vascular homeostasis, and inflammation (miR-126, miR-92a, miR-155, miR-21, miR-23a)

    Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0

  • Change from baseline in arterial lactate levels

    Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0

  • +19 more secondary outcomes

Study Arms (2)

Standard Medical Therapy (Group A)

ACTIVE COMPARATOR

Patients will receive standard medical therapy (SMT) according to local protocols based on international 'Surviving Sepsis Campaign' guidelines.

Other: Standard Medical Therapy (SMT)

CytoSorb Therapy (Group B)

EXPERIMENTAL

Patients will receive standard medical therapy plus a fixed 24-hour continuous hemoadsorption treatment utilizing two sequential CytoSorb cartridges (exchanged at the 12-hour mark).

Device: CytoSorb hemoadsorption

Interventions

CytoSorb hemoadsorptionDEVICE

Target blood flow rate of 1.5 ml/kg/min, implemented either as a standalone extracorporeal treatment or integrated into a CRRT circuit (CVVHDF mode, preferably with regional citrate anticoagulation).

CytoSorb Therapy (Group B)
Standard Medical Therapy (SMT)OTHER

Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines.

Standard Medical Therapy (Group A)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock as defined by Sepsis-3 criteria.
  • Serum lactate levels \>2 and \<8 mmol/L at screening.
  • Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
  • Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose \> 0.5 µg/kg/min.
  • Systemic corticosteroid treatment on board for at least 30 minutes.
  • Tissue perfusion impairment: Persistently elevated serum lactate AND/OR prolonged capillary refill time (\> 3 seconds) despite standard therapy.
  • Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).
  • Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.
  • High likelihood of a dysregulated immune response (PCT ≥ 5 ng/mL AND/OR IL-6 ≥ 1000 pg/mL AND/OR Ferritin ≥ 1000 ng/mL).
  • Written informed, retrospective or prospective consent.

You may not qualify if:

  • Patients under 18 years of age and over 80.
  • Unlikely to survive for 24 hours (Moribund).
  • Pregnancy.
  • SOFA-2 score ≥ 16 at ICU admission.
  • Source control is uncertain.
  • Thrombocytopenia (\<20,000/µL).
  • Criteria of standard guideline-based medical treatment not exhausted.
  • End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2), chronic liver failure (MELD Score \>30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).
  • Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika).

Budapest, 1082, Hungary

Location

MeSH Terms

Conditions

Shock, SepticSepsisVasoplegia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockVascular DiseasesCardiovascular DiseasesPostoperative Complications

Study Officials

  • Zsolt Molnár, Prof. Dr.

    Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary

    PRINCIPAL INVESTIGATOR

  • Péter Hegyi, Prof. Dr.

    Centre for Translational Medicine, Semmelweis University, Budapest, Hungary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamás Tóth, Dr.

CONTACT

+36305399474tomesz9@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 17, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 17, 2026

Record last verified: 2026-06

Locations

HU(1)