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Not yet recruiting NCT07711197

Effects of Hemoadsorption on Vascular Integrity in Septic Shock

No phase Interventional Septic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CytoSorb hemoadsorption, Standard Medical Therapy (SMT).
Who it may be relevant to
Registry conditions: Septic Shock. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial

Overview

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.

Detailed description

This is a prospective, randomised, controlled, open-label, monocentric, proof-of-concept trial. Patients will be randomly assigned in a 1:1 ratio to receive either standard medical therapy alone or standard therapy plus continuous CytoSorb hemoadsorption for 24 hours. Blood samples will be collected at baseline, 6, 12, 18, and 24 hours, and then daily for 5 days to analyze endothelial markers, microRNAs, and inflammatory parameters. An adaptive group sequential design allows for an interim unblinded sample size re-estimation after the first 30 evaluable patients.

Interventions

  • Device CytoSorb hemoadsorption
    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).
  • Other Standard Medical Therapy (SMT)
    Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines.

Primary outcome measures

  • Changes in Syndecan-1 serum levels [Time frame: 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 outcome measures (12)
  • Change in Sequential Organ Failure Assessment (SOFA)-2 score [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in arterial lactate levels [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in procalcitonin concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in C-reactive protein concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in white blood cell count [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in ferritin concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in tumor necrosis factor alpha concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in interleukin-1 beta concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]
  • Change from baseline in interleukin-8 concentration [Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0]

Eligibility criteria

Inclusion criteria

  • 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.
  • Inclusion within a maximum of 12 hours after the onset of vasopressor need.
  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Teráp — Budapest

Identifiers

NCT: NCT07711197 · ADSORP-VIP · 1158 · NNGYK/26060-6/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗