NCT03266302

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 17, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

August 28, 2017

Last Update Submit

March 14, 2025

Conditions

Infective Endocarditis

Keywords

vasodilatory shockhemoadsorptioncardiac surgerycytokines

Outcome Measures

Primary Outcomes (1)

  • SOFA Score

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

    24 hours before until day 9 post-surgery

Secondary Outcomes (6)

  • Overall mortality rate

    until day 30 post surgery

  • Changes in cytokine and cfDNA levels

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

  • SOFA subscores

    24 hours before surgery until day 9 post-surgery

  • Days on ventilator, vasopressor and renal replacement therapy

    until day 30 post-surgery

  • incidence of stroke

    until day 30 post-surgery

  • +1 more secondary outcomes

Study Arms (2)

Interventional group

EXPERIMENTAL

Use 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)

Device: hemoadsorber for removal of cytokines

Control group

NO INTERVENTION

Participants undergoing cardiac surgery due to infective endocarditis will be treated according to Standard of care (no hemoadsorption advice installed in the CPB circuit)

Interventions

hemoadsorber for removal of cytokinesDEVICE

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

Also known as: CytoSorb(R)
Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

University Heart Center Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, D-79189, Germany

Location

University Heart Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany

Location

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

Ulm, Baden-Wurttemberg, D-89081, Germany

Location

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

Cologne, North Rhine-Westphalia, D-50937, Germany

Location

University Hospital Essen, Clinic of Thoracic and Cardiovascular Surgery

Essen, North Rhine-Westphalia, D-45147, Germany

Location

Jena University Hospital, Dept. of Cardiac and Thoracic Surgery

Jena, Thuringia, 07747, Germany

Location

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

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum Brandenburg, Immanuel Klinikum Bernau

Bernau bei Berlin, 16321, Germany

Location

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH, Klinik für Herz- und Thoraxchirurgie

Bochum, 44789, Germany

Location

Universitätsklinikum Bonn, Klinik und Poliklinik für Herzchirurgie

Bonn, 53127, Germany

Location

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

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf, Klinik für Kardiovaskuläre Chirurgie

Düsseldorf, 40225, Germany

Location

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

Halle, 06120, Germany

Location

Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie

Leipzig, 04289, Germany

Location

Related Publications (9)

  • 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.

    PMID: 27059056BACKGROUND

  • 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.

    PMID: 22692171BACKGROUND

  • 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.

    PMID: 24106887BACKGROUND

  • 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.

    PMID: 8993292BACKGROUND

  • 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.

    PMID: 12519925BACKGROUND

  • 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.

    PMID: 19091120BACKGROUND

  • 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.

    PMID: 20212293BACKGROUND

  • 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.

    PMID: 35213213RESULT

  • 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.

    PMID: 32234739DERIVED

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mahmoud Diab, Dr.

    Jena University Hospital, Department of Cardiac and Thoracic Surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not be informed about group allocation
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: two-arm randomized-controlled group sequential (Pocock) design for assessing superiority and safety
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

August 30, 2017

Study Start

January 17, 2018

Primary Completion

February 28, 2020

Study Completion

December 31, 2020

Last Updated

March 18, 2025

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(14)