Cytokine Hemoadsorption During Cardiac Surgery Versus Standard Surgical Care for Infective Endocarditis (REMOVE): Results From a Multicenter Randomized Controlled Trial

被引:99
作者
Diab, Mahmoud [1 ,2 ]
Lehmann, Thomas [2 ,3 ]
Bothe, Wolfgang [9 ]
Akhyari, Payam [10 ]
Platzer, Stephanie [2 ,3 ]
Wendt, Daniel [11 ]
Deppe, Antje-Christin [12 ]
Strauch, Justus [13 ]
Hagel, Stefan [4 ]
Guenther, Albrecht [5 ]
Faerber, Gloria [1 ]
Sponholz, Christoph [6 ]
Franz, Marcus [7 ]
Scherag, Andre [2 ,3 ,8 ]
Velichkov, Ilia [1 ]
Silaschi, Miriam [14 ]
Fassl, Jens [15 ]
Hofmann, Britt [16 ]
Lehmann, Sven [17 ]
Schramm, Rene [18 ]
Fritz, Georg [19 ]
Szabo, Gabor [16 ]
Wahlers, Thorsten [12 ]
Matschke, Klaus [20 ]
Lichtenberg, Artur [10 ]
Pletz, Mathias W. [4 ]
Gummert, Jan F. [18 ]
Beyersdorf, Friedhelm [9 ]
Hagl, Christian [21 ,22 ]
Borger, Michael A. [17 ]
Bauer, Michael [2 ,6 ]
Brunkhorst, Frank M. [2 ,3 ]
Doenst, Torsten [1 ]
机构
[1] Friedrich Schiller Univ Jena, Dept Cardiothorac Surg, Jena Univ Hosp, Jena, Germany
[2] Friedrich Schiller Univ Jena, Ctr Sepsis Control & Care, Jena Univ Hosp, Jena, Germany
[3] Friedrich Schiller Univ Jena, Ctr Clin Studies, Jena Univ Hosp, Jena, Germany
[4] Friedrich Schiller Univ Jena, Inst Infect Dis & Infect Control, Jena Univ Hosp, Jena, Germany
[5] Friedrich Schiller Univ Jena, Dept Neurol, Jena Univ Hosp, Jena, Germany
[6] Friedrich Schiller Univ Jena, Dept Anesthesiol & Crit Care Med, Jena Univ Hosp, Jena, Germany
[7] Friedrich Schiller Univ Jena, Dept Internal Med 1, Jena Univ Hosp, Jena, Germany
[8] Friedrich Schiller Univ Jena, Inst Med Stat Comp & Data Sci, Jena Univ Hosp, Jena, Germany
[9] Univ Heart Ctr Freiburg Bad Krozingen, Dept Cardiovasc Surg, Freiburg, Germany
[10] Heinrich Heine Univ Duesseldorf, Dept Cardiothorac Surg, Dusseldorf, Germany
[11] Univ Hosp Essen, Dept Thorac & Cardiovasc Surg, Essen, Germany
[12] Univ Cologne, Dept Cardiothorac Surg, Heart Ctr, Colonge, Germany
[13] Bergmannsheil Univ Hosp, Dept Cardiac & Thorac Surg, Bochum, Germany
[14] Univ Hosp Bonn, Clin & Polyclin Cardiac Surg, Bonn, Germany
[15] Tech Univ Dresden, Univ Hosp, Inst Cardiac Anesthesiol, Dresden Heart Ctr, Dresden, Germany
[16] Univ Hosp Halle Saale, Dept Cardiac Surg, Midgerman Heart Ctr, Halle, Germany
[17] Heart Ctr Leipzig, Dept Cardiac Surg, Leipzig, Germany
[18] Heart & Diabet Ctr NRW, Dept Thorac & Cardiovasc Surg, Bad Oeynhausen, Germany
[19] Heart Ctr Brandenburg, Dept Anesthesiol Intens Care & Pain Therapy, Immanuel Clin Bernau, Brandenburg, Germany
[20] Heart Ctr Dresden, Dept Cardiac Surg, Dresden, Germany
[21] Ludwig Maximilian Univ Munich, Dept Cardiac Surg, Munich, Germany
[22] DZHK German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany
关键词
cardiopulmonary bypass; cytokines; endocarditis; thoracic surgery; TUMOR-NECROSIS-FACTOR; SHORT-TERM SURVIVAL; CARDIOPULMONARY BYPASS; SEPSIS; ADSORPTION; HEMOFILTRATION; INTERLEUKIN-6;
D O I
10.1161/CIRCULATIONAHA.121.056940
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND: Cardiac surgery often represents the only treatment option in patients with infective endocarditis (IE). However, IE surgery may lead to a sudden release of inflammatory mediators, which is associated with postoperative organ dysfunction. We investigated the effect of hemoadsorption during IE surgery on postoperative organ dysfunction. METHODS: This multicenter, randomized, nonblinded, controlled trial assigned patients undergoing cardiac surgery for IE to hemoadsorption (integration of CytoSorb to cardiopulmonary bypass) or control. The primary outcome (change in sequential organ failure assessment score [Delta SOFA]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score. The analysis was by modified intention to treat. A predefined intergroup comparison was performed using a linear mixed model for Delta SOFA including surgeon and baseline SOFA score as fixed effect covariates and with the surgical center as random effect. The SOFA score assesses dysfunction in 6 organ systems, each scored from 0 to 4. Higher scores indicate worsening dysfunction. Secondary outcomes were 30-day mortality, duration of mechanical ventilation, and vasopressor and renal replacement therapy. Cytokines were measured in the first 50 patients. RESULTS: Between January 17, 2018, and January 31, 2020, a total of 288 patients were randomly assigned to hemoadsorption (n=142) or control (n=146). Four patients in the hemoadsorption and 2 in the control group were excluded because they did not undergo surgery. The primary outcome, Delta SOFA, did not differ between the hemoadsorption and the control group (1.79 +/- 3.75 and 1.93 +/- 3.53, respectively; 95% CI, -1.30 to 0.83; P=0.6766). Mortality at 30 days (21% hemoadsorption versus 22% control; P=0.782), duration of mechanical ventilation, and vasopressor and renal replacement therapy did not differ between groups. Levels of interleukin-1 beta and interleukin-18 at the end of integration of hemoadsorption to cardiopulmonary bypass were significantly lower in the hemoadsorption than in the control group. CONCLUSIONS: This randomized trial failed to demonstrate a reduction in postoperative organ dysfunction through intraoperative hemoadsorption in patients undergoing cardiac surgery for IE. Although hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, there was no difference in any of the clinically relevant outcome measures.
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收藏
页码:959 / 968
页数:10
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