Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03892174

Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)

Infectious endocarditis (IE) and other severe infections are well-known to induce significant changes in the immune response including immune functionality in a considerable number of affected patients. In fact, numerous patients with IE develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/or functional anergy. This was previously referred to as "injury-associated immunosuppression (IAI)" by Pfortmüller et al., published in Intensive Care Medicine Experimental 2017. IAI can be assessed by measurement of cellular (functional) markers. Persistence of IAI is associated with prolonged ICU length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in immunostimulatory (randomized controlled) clinical trials. CytoSorb® treatment is currently used as standard of care in some institutions in surgically treated IE patients. The investigators aim to investigate two accepted treatment protocols and aim to explore whether adsorption with a cytokine adsorption filter can increase immune competence in treated individuals.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Endocarditis Cardiovascular Diseases Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Intensive Care Medicine

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Joerg C Schefold, MD

CONTACT

[email protected]

Lars Englberger, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects scheduled for routine cardiac surgery for infectious endocarditis (diagnosed according to the predefined "DUKE" criteria) with antibiotic therapy for ≤ 14 days.
  • Presence of informed consent
  • Age ≥18 yrs.

Exclusion criteria

  • Previous treatment (last 6 months) with immunologically-active biologicals or specific immunomodulatory drugs (e.g. Rituximab)
  • high-dose chronic (i.e. before onset of infectious endocarditis) steroid medication with prednisone equivalent of >30 mg/d
  • Patients on Extracorporeal membrane oxygenation (ECMO), or any other (pre-operative) cardiac assist device
  • Moribund patient (life expectancy <14 days)

Treatment and study plan

Treatment protocol with adsorption

Other

Adsorption while patients are in the OR on the extracorporeal circuit

Primary outcomes

  1. Change in quantitative expression of monocytic Human Leukocyte Antigen (mHLA)-DR expression (Antibodies per cell on Cluster of Differentiation (CD)14+ monocytes/macrophages, assessed using a quantitative standardized assay)

    Time frame: From baseline (pre-OR, t1) to day 1 post-OR (t3)

Secondary outcomes

  1. Change in mHLA-DR from baseline (pre-OR) to post-Or and 3 days post-Or.

    Time frame: Baseline (pre-OP) to post-OR and 3 days post-Or

    Course of mHLA-DR

  2. Area under the curve of quantitative mHLA-DR expression

    Time frame: Between baseline (pre-OR), post-OR, and day 1 and 3 post-OR (multiple assessments).

    Area under the curves mHLA-DR

  3. Change in inflammatory markers including cytokines (Interleukin (IL)-6, IL-10, C-reactive protein, White blood cell count, multiplex Enzyme linked immunosorbent assay, and inflammatory prohormones)

    Time frame: From baseline (pre-OR) to post-OR, and day 1 and 3 post-OR

    Change in inflammatory parameters

  4. Change in organ dysfunction (Sepsis-related organ failure (SOFA) scores incl. subscores and Simplified acute physiology score (SAPS II scores) daily

    Time frame: 7-day timeframe (starting from ICu admission, assessed at day 90)

    Course of organ dysfunction

  5. Length of ICU and hospital stay (days after surgical intervention).

    Time frame: Number of days on ICU and in hospital (assessed at day 90)

    Length of stay

  6. Cumulative Therapeutic Intervention Scoring System (TISS) points (resource need) until ICU-discharge

    Time frame: Total number of TISS points on ICU (cumulative), assessed at day 90

    Resource use

  7. Total amount of infused volume/transfusions on ICU

    Time frame: 90 days

    Need for fluid therapy

  8. Duration of vasoactive drug therapy

    Time frame: 90 days

    Vasopressor use

  9. Duration of invasive mechanical ventilation

    Time frame: 90 days

    Use of organ support therapy (number of days on mechanical ventilation)

  10. ICU mortality rate

    Time frame: ICU stay (assessed at day 90)

    Number of non-surviving patients in both study groups

  11. Hospital mortality rate

    Time frame: hospital stay (assessed at day 90)

    Number of non-surviving patients in both study groups

  12. 28 day mortality rate

    Time frame: 28 days beginning from ICU admission (assessed at day 90)

    Number of non-surviving patients in both study groups

  13. 90 day mortality rate

    Time frame: 90 days beginning from ICU admission (assessed at day 90)

    Number of non-surviving patients in both study groups

  14. Duration of renal replacement therapy

    Time frame: 90 days

    Use of organ support therapy (number of days on renal replacement therapy)

Study contacts

Contact information is provided by the study sponsor or research team.

Joerg C Schefold, MD

CONTACT

[email protected]

0041-31-632 ext. 5397

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE) - an Investigator-initiated Prospective Randomized Controlled Clinical Trial Comparing Two Established Clinical Protocols

Acronym: RECREATE

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2019
Registry last updated
Nov 12, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.