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Infective EndocarditisREMOVENCT03266302

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

A study testing hemoadsorber for removal of cytokines in people with Infective Endocarditis, run by Jena University Hospital at 14 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infective Endocarditis
What is being tested?
hemoadsorber for removal of cytokines
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
14 sitesGermany
Study dates
17 Jan 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • University Heart Center Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, D-79189

  • Herz- und Diabeteszentrum NRW, Klinik für Thorax- und Kardiovaskularchirurgie

    Bad Oeynhausen, 32545

  • Herzzentrum Brandenburg, Immanuel Klinikum Bernau

    Bernau bei Berlin, 16321

  • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie

    Bochum, 44789

  • Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie

    Bonn, 53127

  • University Hospital Cologne, Clinic and Policlinics for Heart and Thoracic Surgery

    Cologne, North Rhine-Westphalia, D-50937

  • Herzzentrum Dresden GmbH, Universitätsklinik an der TU Dresden, Klinik für Herzchirurgie

    Dresden, 01307

  • Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie

    Düsseldorf, 40225

  • University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery

    Essen, North Rhine-Westphalia, D-45147

  • University Heart Center Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, D-79106

  • Mitteldeutsches Herzzentrum, Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Herzchirurgie

    Halle, 06120

  • Jena University Hospital, Dept. of Cardiac and Thoracic Surgery

    Jena, Thuringia, 07747

  • Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie

    Leipzig, 04289

  • University Hospital Ulm, Clinics of Heart-, Thoracic and Cardiovascular Surgery

    Ulm, Baden-Wurttemberg, D-89081

Other trials in Germany

About this study

Official 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

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.

Read the detailed description

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.

Being tested
hemoadsorber for removal of cytokines
Keywords
vasodilatory shock, hemoadsorption, cardiac surgery, cytokines
Medical subject headings
Endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hemoadsorber for removal of cytokinesDevice

    Also called CytoSorb(R)

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

Study groups in NCT03266302
Study groupRoleWhat they receive
Interventional groupExperimentalUse of hemoadsorber for removal of cytokines. Participants undergoing cardiac surgery due to infective endocarditis will be treated using a hemoadsorption device (CytoSorb) within the cardiopulmonary Bypass circuit (=Intervention)
Receives: Device: hemoadsorber for removal of cytokines
Control groupNo interventionParticipants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SOFA Score

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

    Measured: 24 hours before until day 9 post-surgery

Secondary outcomes (6)

  1. Overall mortality rate

    Overall mortality rate until day 30 post-surgery

    Measured: until day 30 post surgery

  2. Changes in cytokine and cfDNA levels

    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

    Measured: 24 hours before, during cardiac surgery and 24 hours after surgery

  3. SOFA subscores

    single SOFA subscores will be analyzed

    Measured: 24 hours before surgery until day 9 post-surgery

  4. Days on ventilator, vasopressor and renal replacement therapy

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

    Measured: until day 30 post-surgery

  5. incidence of stroke

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

    Measured: until day 30 post-surgery

  6. length of ICU and in-hospital stay

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

    Measured: until day 30 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start17 Jan 2018
  3. Primary completion28 Feb 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Model description
two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety
Masking
Single blind
Who is masked
Participant
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266302
Sponsor's protocol ID
ZKSJ0108
Acronym
REMOVE
Status last verified
Mar 2020
First submitted
28 Aug 2017
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.

    PubMed 27059056

  • Brunkhorst FM, Oppert M, Marx G, Bloos F, Ludewig K, Putensen C, Nierhaus A, Jaschinski U, Meier-Hellmann A, Weyland A, Grundling M, Moerer O, Riessen R, Seibel A, Ragaller M, Buchler MW, John S, Bach F, Spies C, Reill L, Fritz H, Kiehntopf M, Kuhnt E, Bogatsch H, Engel C, Loeffler M, Kollef MH, Reinhart K, Welte T; German Study Group Competence Network Sepsis (SepNet). Effect of empirical treatment with moxifloxacin and meropenem vs meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA. 2012 Jun 13;307(22):2390-9. doi: 10.1001/jama.2012.5833.

    PubMed 22692171

  • Bustamante J, Arevalo A, Tamayo E, Sarria C, Aguilar-Blanco EM, Heredia M, Almansa R, Rico L, Iglesias V, Bermejo-Martin JF. Cytokine profiles linked to fatal outcome in infective prosthetic valve endocarditis. APMIS. 2014 Jun;122(6):526-9. doi: 10.1111/apm.12189. Epub 2013 Sep 30.

    PubMed 24106887

  • Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.

    PubMed 8993292

  • Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.

    PubMed 12519925

  • Minne L, Abu-Hanna A, de Jonge E. Evaluation of SOFA-based models for predicting mortality in the ICU: A systematic review. Crit Care. 2008;12(6):R161. doi: 10.1186/cc7160. Epub 2008 Dec 17.

    PubMed 19091120

  • Prendergast BD, Tornos P. Surgery for infective endocarditis: who and when? Circulation. 2010 Mar 9;121(9):1141-52. doi: 10.1161/CIRCULATIONAHA.108.773598. No abstract available.

    PubMed 20212293

  • Diab M, Lehmann T, Bothe W, Akhyari P, Platzer S, Wendt D, Deppe AC, Strauch J, Hagel S, Gunther A, Faerber G, Sponholz C, Franz M, Scherag A, Velichkov I, Silaschi M, Fassl J, Hofmann B, Lehmann S, Schramm R, Fritz G, Szabo G, Wahlers T, Matschke K, Lichtenberg A, Pletz MW, Gummert JF, Beyersdorf F, Hagl C, Borger MA, Bauer M, Brunkhorst FM, Doenst T; REMOVE Trial Investigators*. Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial. Circulation. 2022 Mar 29;145(13):959-968. doi: 10.1161/CIRCULATIONAHA.121.056940. Epub 2022 Feb 25.

    PubMed 35213213

  • Diab M, Platzer S, Guenther A, Sponholz C, Scherag A, Lehmann T, Velichkov I, Hagel S, Bauer M, Brunkhorst FM, Doenst T. Assessing efficacy of CytoSorb haemoadsorber for prevention of organ dysfunction in cardiac surgery patients with infective endocarditis: REMOVE-protocol for randomised controlled trial. BMJ Open. 2020 Mar 30;10(3):e031912. doi: 10.1136/bmjopen-2019-031912.

    PubMed 32234739

Questions about this trial

What is this clinical trial studying?

A study testing hemoadsorber for removal of cytokines in people with Infective Endocarditis, run by Jena University Hospital at 14 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOFA Score (time frame: 24 hours before until day 9 post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266302, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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