Background <p>To characterize current clinical practices and outcomes associated with the use of the extracorporeal blood purification (EBP) device Oxiris® in critically ill patients.</p> Methods <p>This was a prospective clinical registry database that analyzed patients treated with Oxiris®. Three different clusters of critically ill patients were identified: Group A—patients with chronic kidney disease and systemic inflammation who required postoperative support of renal function; Group B—patients requiring immunomodulation without definitive indications for renal support; Group C—patients with abdominal septic shock necessitating both postoperative renal support and immunomodulation. The primary endpoint was the comparison between mortality rates predicted by the Simplified Acute Physiology Score II (SAPS II) and observed mortality rates 4&#xa0;days after EBP initiation.</p> Results <p>Observed 4-day mortality rates were markedly lower than SAPS II-predicted rates: 16.7% vs. 41% in Group A, 30.8% vs. 77% in Group B, and 21.3% vs. 83% [66;89] in Group C. Early mortality was significantly associated with baseline hemodynamic instability (vasopressor requirement, OR = 3.62 [1.59–9.80], <i>p</i> = 0.005) and a lower PaO₂/FiO₂ ratio (OR = 0.99 [0.98–0.99], <i>p</i> = 0.001).</p> Conclusions <p>The removal of inflammatory mediators and microbial components is an emerging therapeutic target for Oxiris® use. Oxiris® may offer therapeutic benefit through the removal of inflammatory mediators in critically ill patients with severe systemic inflammation and renal failure. Although observed mortality was lower than historical estimates, these findings must be interpreted cautiously given the lack of a control group and the limitations of SAPS II. Controlled trials are needed to confirm its clinical impact.</p> Trial registration <p>The study was registered on ClinicalTrials.gov (Identifier: NCT03807414; Registration Date: June 28, 2019).</p>

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Use of Oxiris membrane in real-world clinical practice in critical care patients: a multicenter observational study

  • Gianluca Villa,
  • Antonio Fioccola,
  • Matteo Cecchi,
  • Caterina Scirè Calabrisotto,
  • Diego Pomarè Montin,
  • Silvia De Rosa,
  • Giulia Scoccia,
  • Andrea Manno,
  • Lorenzo Tofani,
  • Clemente Santorsola,
  • Francesco Patera,
  • Alessandro Capitanini,
  • Marco Vittorio Resta,
  • Fiorenza Ferrari,
  • Massimiliano Greco,
  • Fabrizio Rossi,
  • Zaccaria Ricci,
  • Claudio Ronco,
  • Stefano Romagnoli,
  • Alessio Altomare,
  • Marco Anderloni,
  • Elena Angeli,
  • Andrea Ballin,
  • Matteo Brivio,
  • Paolo Boninsegni,
  • Vittorio Bocciero,
  • Francesco Caccavale,
  • Carlo Coniglio,
  • Francesco Coppolino,
  • Alberto Corona,
  • Luigi d’Auria,
  • Luca Di Girolamo,
  • Katia Donadello,
  • Lorenzo Fontanarosa,
  • Ilaria Godi,
  • Leonardo Gottin,
  • Glauco Salvatore Juliano,
  • Sergio Lassola,
  • Francesco Magiotti,
  • Raffaele Mandarano,
  • Emilpaolo Manno,
  • Paola Marino,
  • Gaetano Mautone,
  • Tommaso Meconi,
  • Santo Morabito,
  • Giuseppe Olivo,
  • Maria Caterina Pace,
  • Vittorio Pavoni,
  • Valentina Pistolesi,
  • Vincenzo Pota,
  • Federico Prato,
  • Giuseppe Rotondo,
  • Sara Samoni,
  • Pasquale Sansone,
  • Daniela Sechi,
  • Gianluca Spinelli,
  • Marco Tengattini,
  • Eleonora Terreni,
  • Marika Claire Theriault,
  • Ivo Tiberio,
  • Franco Turani,
  • Brunilda Xhaferi

摘要

Background

To characterize current clinical practices and outcomes associated with the use of the extracorporeal blood purification (EBP) device Oxiris® in critically ill patients.

Methods

This was a prospective clinical registry database that analyzed patients treated with Oxiris®. Three different clusters of critically ill patients were identified: Group A—patients with chronic kidney disease and systemic inflammation who required postoperative support of renal function; Group B—patients requiring immunomodulation without definitive indications for renal support; Group C—patients with abdominal septic shock necessitating both postoperative renal support and immunomodulation. The primary endpoint was the comparison between mortality rates predicted by the Simplified Acute Physiology Score II (SAPS II) and observed mortality rates 4 days after EBP initiation.

Results

Observed 4-day mortality rates were markedly lower than SAPS II-predicted rates: 16.7% vs. 41% in Group A, 30.8% vs. 77% in Group B, and 21.3% vs. 83% [66;89] in Group C. Early mortality was significantly associated with baseline hemodynamic instability (vasopressor requirement, OR = 3.62 [1.59–9.80], p = 0.005) and a lower PaO₂/FiO₂ ratio (OR = 0.99 [0.98–0.99], p = 0.001).

Conclusions

The removal of inflammatory mediators and microbial components is an emerging therapeutic target for Oxiris® use. Oxiris® may offer therapeutic benefit through the removal of inflammatory mediators in critically ill patients with severe systemic inflammation and renal failure. Although observed mortality was lower than historical estimates, these findings must be interpreted cautiously given the lack of a control group and the limitations of SAPS II. Controlled trials are needed to confirm its clinical impact.

Trial registration

The study was registered on ClinicalTrials.gov (Identifier: NCT03807414; Registration Date: June 28, 2019).