Blood filter could shield vessels in septic shock

NCT ID NCT07711197

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
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First seen Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This trial investigates whether a blood-filtering device called CytoSorb can reduce damage to blood vessels in people with septic shock, a life-threatening condition. The device removes inflammatory molecules from the blood. Researchers will measure changes in a marker of vessel injury and track organ function in 110 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CytoSorb hemoadsorption device used to filter blood and remove inflammatory molecules
What this could lead to
If successful, this approach could offer a new way to stabilize blood vessels and reduce organ failure in septic shock, potentially saving lives.
What could go wrong
This is a relatively small, early-stage trial, and the treatment may not improve outcomes or could cause complications like bleeding or clotting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Sepsis toxic shock syndrome Vasoplegia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Budapest, 1082, Hungary

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