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.

Gisler, Fabian; Spinetti, Thibaud; Erdoes, Gabor; Luedi, Markus M.; Pfortmueller, Carmen A.; Messmer, Anna S.; Jenni, Hansjörg; Englberger, Lars; Schefold, Joerg C. (2020). 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. Medicine, 99(15), e19580. Lippincott Williams & Wilkins 10.1097/MD.0000000000019580

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INTRODUCTION Infective endocarditis (IE) and other severe infections induce significant changes in the immune response in a considerable number of affected patients. Numerous IE patients develop a persistent functional immunological phenotype that can best be characterized by a profound anti-inflammation and/ or functional "anergy." This is pronounced in patients with unresolved infectious foci and was previously referred to as "injury-associated immunosuppression" (IAI). IAI can be assessed by measurement of the monocytic human leukocyte antigen-DR (mHLA-DR) expression, a global functional marker of immune competence. Persistence of IAI is associated with prolonged intensive care unit length of stay, increased secondary infection rates, and death. Immunomodulation to reverse IAI was shown beneficial in early immunostimulatory (randomized controlled) clinical trials. METHODS Prospective 1:1 randomized controlled clinical study to compare the course of mHLA-DR in patients scheduled for cardiac surgery for IE. Patients will receive either best standard of care plus cytokine adsorption during surgery while on cardiopulmonary bypass (protocol A) versus best standard of care alone, that is, surgery without cytokine adsorption (protocol B). A total of 54 patients will be recruited and randomized. The primary endpoint is a change in quantitative expression of mHLA-DR (antibodies per cell on CD14+ monocytes/ macrophages, assessed using a quantitative standardized assay) from baseline (preoperation [pre-OP], visit 1) to day 1 post-OP (visit 4). DISCUSSION This randomized controlled clinical trial (RECReATE) will compare 2 clinical treatment protocols and will investigate whether cytokine adsorption restores monocytic immune competence (reflected by increased mHLA-DR expression) in patients with IE undergoing cardiac surgery. TRIAL REGISTRATION This protocol was registered in ClinicalTrials.gov, under number NCT03892174, first listed on March 27, 2019.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiovascular Surgery
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic and Policlinic for Anaesthesiology and Pain Therapy
04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Gisler, Fabian; Spinetti, Thibaud; Erdös, Gabor; Lüdi, Markus; Pfortmüller, Carmen; Messmer, Anna Sarah; Jenni, Hansjoerg; Englberger, Lars and Schefold, Jörg Christian

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0025-7974

Publisher:

Lippincott Williams & Wilkins

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

23 Apr 2020 14:16

Last Modified:

26 Apr 2020 02:47

Publisher DOI:

10.1097/MD.0000000000019580

PubMed ID:

32282706

BORIS DOI:

10.7892/boris.143353

URI:

https://boris.unibe.ch/id/eprint/143353

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