NCT07679555

Brief Summary

This single-center retrospective observational cohort study aims to evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in critically ill adult patients treated in the Intensive Care Unit of Flór Ferenc Hospital, Hungary, between January 1, 2020, and May 31, 2026. Patients who received CytoSorb® or Efferon LPS® hemoadsorption therapy will be included. The study will assess changes in vasopressor requirements, hemodynamic parameters, inflammatory biomarkers, liver function tests, tissue perfusion markers, and oxygenation following hemoadsorption treatment. Clinical outcomes, including intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality, will also be evaluated. Data will be collected retrospectively from anonymized medical records, and no study-related interventions will be performed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress98%
Jan 2020Sep 2026

Study Start

First participant enrolled

January 1, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

6.4 years

First QC Date

June 25, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

hemoadsorptionCytoSorbEfferon LPSVasoactive Inotropic ScoreVasopressor Dependency IndexShock reversal timeBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy

    The primary endpoint is the change in vasopressor and inotropic support requirements, quantified using the Vasoactive Inotropic Score (VIS), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment. VIS is calculated as: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10 × vasopressin (U/kg/min)

    Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy

Secondary Outcomes (4)

  • Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy

    Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.

  • Shock Reversal Time (SRT)

    From initiation of hemoadsorption therapy until achievement of shock reversal, assessed during the first 24 hours after completion of hemoadsorption therapy.

  • Change in laboratory biomarkers from baseline to immediately after and 24 hours after completion of hemoadsorption therapy

    Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.

  • Change in oxygenation (PaO₂/FiO₂ ratio) from baseline to immediately after and 24 hours after completion of hemoadsorption therapy

    Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.

Other Outcomes (5)

  • Change in Sequential Organ Failure Assessment (SOFA) score from baseline to Day 2 (24 hours after completion of hemoadsorption therapy)

    Baseline (immediately before hemoadsorption therapy) and 24 hours after completion of hemoadsorption therapy.

  • Length of stay in the intensive care unit (ICU)

    From ICU admission until ICU discharge (up to 90 days).

  • ICU mortality

    From ICU admission until ICU discharge (up to 90 days).

  • +2 more other outcomes

Study Arms (1)

Patients receiving hemoadsorption treatment

Critically ill patients who received hemoadsorption therapy using CytoSorb or Efferon LPS between January 1 2020 and May 31 2026

Procedure: Hemoadsorption

Interventions

Patients included in this retrospective observational study received adjunctive hemoadsorption therapy as part of routine clinical care at the discretion of the treating intensive care physicians. Hemoadsorption was performed using either the CytoSorb® or Efferon LPS® hemoadsorption cartridge, according to the clinical indication and device availability. Hemoadsorption was integrated into a continuous renal replacement therapy (CRRT) circuit. Treatment duration, number of hemoadsorption sessions, timing of therapy initiation, and concomitant intensive care interventions were determined by the treating physicians and were not influenced by the study protocol. No study-specific interventions, additional diagnostic procedures, or protocol-mandated treatments were performed.

Patients receiving hemoadsorption treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be retrospective. Patients who received adjunctive hemoadsorption therapy at the Department of Anesthesiology and Intensive Care of Flór Ferenc Hospital between January 1, 2020, and May 31, 2026, will be included in the study.

You may qualify if:

  • \>18 years;
  • CytoSorb or Efferon LPS hemoadsorption treatment,
  • with available relevant pre- and post-treatment clinical and laboratory data

You may not qualify if:

  • age under 18 years
  • missing key demographic or outcome data;
  • unknown treatment type or timing;
  • data unavailable for legal or ethical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pest County Flór Ferenc Hospital, Dept. of Anaesthesiology and Intensive Therapy

Kistarcsa, Pest County, 2143, Hungary

RECRUITING

Study Officials

  • Zoltán Ruszkai, MD, PhD

    Pest County Flór Ferenc Hospital

    STUDY DIRECTOR

Central Study Contacts

Zoltán Ruszkai, MD, PhD

CONTACT

Gergely Bokrétás, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Anesthesiology and Intensive Therapy

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

January 1, 2020

Primary Completion

May 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

No identifiable individual participant data will be collected. All patient-level data will be anonymized, and no IPD will be made available for sharing.

Locations