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NCT Number: NCT03266302

Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis

Infective endocarditis (IE) is associated with high hospital mortality for various reasons; one of them is circulatory failure in patients who undergo cardiac surgery for IE. One discussed reason underlying circulatory failure during surgery is the release of vasodilatatory mediators and cytokines. This study examines the efficacy and safety of a hemoadsorption filter which is approved for the reduction of the concentration of cytokines in the bloodstream.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Heart Center Bad Krozingen, Bad Krozingen, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

The investigators assume a common standard deviation of 3.8 points and that a 1.4-point lower SOFA score in the Intervention Group is of clinical relevance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with infective endocarditis (according to DUKE criteria) undergoing cardiac surgery
  • informed consent
  • age ≥18 years

Exclusion criteria

  • EuroScoreII ≤ 3
  • current participation in another interventional Trial
  • pregnancy
  • current immunosuppressive or immunomodulatory therapy (with dosing of glucocorticoids over Cushing threshold)
  • previous participation in the REMOVE study

Treatment and study plan

hemoadsorber for removal of cytokines

Device

Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.

Other names: CytoSorb(R)

Primary outcomes

  1. SOFA Score

    Time frame: 24 hours before until day 9 post-surgery

    The investigators will test if mean SOFA scores are different for the experimental and control group.

Secondary outcomes

  1. Overall mortality rate

    Time frame: until day 30 post surgery

    Overall mortality rate until day 30 post-surgery

  2. Changes in cytokine and cfDNA levels

    Time frame: 24 hours before, during cardiac surgery and 24 hours after surgery

    changes in cytokine and cfDNA levels will be measured at different time points before, during and after surgery in both groups; only for the first 2x25 patients

  3. SOFA subscores

    Time frame: 24 hours before surgery until day 9 post-surgery

    single SOFA subscores will be analyzed

  4. Days on ventilator, vasopressor and renal replacement therapy

    Time frame: until day 30 post-surgery

    Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed

  5. incidence of stroke

    Time frame: until day 30 post-surgery

    incidence of stroke within 30 days post-surgery will be assessed

  6. length of ICU and in-hospital stay

    Time frame: until day 30 post-surgery

    total length of ICU and in-hospital stay until day 30 post-surgery

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • CytoSorbents, Inc
  • Fraunhofer Institute for Interfacial Engineering and Biotechnology
  • German Federal Ministry of Education and Research
  • Thermo Fisher Scientific, Inc

Registry information

Official study title

Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients With Infective Endocarditis - a Multicentric Randomized Controlled Group Sequential Trial

Acronym: REMOVE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2017
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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