Evaluation of MP4OX for prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia: a randomized, double-blind, multicenter study
Christina I Olofsson, Andrzej Z Górecki, Ris Dirksen, Ivo Kofranek, Jacek A Majewski, Tomasz Mazurkiewicz, David Jahoda, Bengt Fagrell, Peter E Keipert, Yun J Hardiman, Howard Levy, Study 6084 Clinical Investigators, Mona Momeni, Barbara Brui, Valerie Collet, Sven Van Poucke, René J Heylen, Ria Hens, Piet J Libbrecht, Bruno De Turck, Lieve D'haenen, Jean-Claude De Mey, Ludwig Deruyck, Marcel Vercauteren, Ellen Hendrickx, Luc Sermeus, Vera Saldien, Carine Smitz, Ivo Kofránek, Petr Hajny, Alan Konopásek, Radouan Kubes, Martin Kafunek, Lucie Kompelentova, Ivana Stastna, David Jahoda, Lubos Vcela, Jan Tomaides, David Pokomy, Rastislav Hromadka, Antonin Sosna, Alena Hykesova, David Pellar, David Dolezal, Magdalena Winklerova, Thomas Novak, Petr Nekvinda, Petra Valova, Ris Dirksen, Cornelius Gort, Ineke Bergshoeff, Florent Luijkx, Gert Jan Scheffer, Gert-Jan van Geffen, Judith Beurskens-Meijerink, Jacek A Majewski, Rafal Szczygiel, Jacek Hermanson, Jan Pajak, Andrzej Z Górecki, Piotr Nowakowski, Pawel Skowronek, Radoslaw Gorski, Paweł Olszewski, Tomasz Mazurkiewicz, Agnieszka Koman-Izko, Jan Blacha, Robert Wegkowski, Maciej Janosz Patyra, Tadeusz Gazdzik, Marek Bozek, Tomasz Bielecki, Alberski Ewa Kuk, Christina I Olofsson, Eva-Britt Nygards, Sinnika Omaniemi Olsson, Sixten Bredbacka, Caroline Hällsjö-Sander, Anders Ekelund, Ritva Thule, Anders Winterfeldt, Eva Nordenskjöld, Carl Erik Högman, Alan Aitkenhead, Jon Hardman, Christina I Olofsson, Andrzej Z Górecki, Ris Dirksen, Ivo Kofranek, Jacek A Majewski, Tomasz Mazurkiewicz, David Jahoda, Bengt Fagrell, Peter E Keipert, Yun J Hardiman, Howard Levy, Study 6084 Clinical Investigators, Mona Momeni, Barbara Brui, Valerie Collet, Sven Van Poucke, René J Heylen, Ria Hens, Piet J Libbrecht, Bruno De Turck, Lieve D'haenen, Jean-Claude De Mey, Ludwig Deruyck, Marcel Vercauteren, Ellen Hendrickx, Luc Sermeus, Vera Saldien, Carine Smitz, Ivo Kofránek, Petr Hajny, Alan Konopásek, Radouan Kubes, Martin Kafunek, Lucie Kompelentova, Ivana Stastna, David Jahoda, Lubos Vcela, Jan Tomaides, David Pokomy, Rastislav Hromadka, Antonin Sosna, Alena Hykesova, David Pellar, David Dolezal, Magdalena Winklerova, Thomas Novak, Petr Nekvinda, Petra Valova, Ris Dirksen, Cornelius Gort, Ineke Bergshoeff, Florent Luijkx, Gert Jan Scheffer, Gert-Jan van Geffen, Judith Beurskens-Meijerink, Jacek A Majewski, Rafal Szczygiel, Jacek Hermanson, Jan Pajak, Andrzej Z Górecki, Piotr Nowakowski, Pawel Skowronek, Radoslaw Gorski, Paweł Olszewski, Tomasz Mazurkiewicz, Agnieszka Koman-Izko, Jan Blacha, Robert Wegkowski, Maciej Janosz Patyra, Tadeusz Gazdzik, Marek Bozek, Tomasz Bielecki, Alberski Ewa Kuk, Christina I Olofsson, Eva-Britt Nygards, Sinnika Omaniemi Olsson, Sixten Bredbacka, Caroline Hällsjö-Sander, Anders Ekelund, Ritva Thule, Anders Winterfeldt, Eva Nordenskjöld, Carl Erik Högman, Alan Aitkenhead, Jon Hardman
Abstract
Background: MP4OX (oxygenated polyethylene glycol-modified hemoglobin) is an oxygen therapeutic agent with potential applications in clinical settings where targeted delivery of oxygen to ischemic tissues is required. The primary goal of this study was to investigate MP4OX for preventing hypotensive episodes. An additional goal was to establish the safety profile of MP4OX in a large surgical population.
Methods: Patients (n = 367) from 18 active study sites in six countries, undergoing elective primary hip arthroplasty with spinal anesthesia, were randomized to receive MP4OX or hydroxyethyl starch 130/0.4. Patients received a 250-ml dose at induction of spinal anesthesia and a second 250-ml dose if the protocol-specified trigger (predefined decrease in systolic blood pressure) was reached. The primary end point was the proportion of patients who developed one or more hypotensive episodes.
Results: The proportion of patients with one or more hypotensive episodes was significantly lower (P < 0.0001) in the MP4OX group (66.1%) versus controls receiving hydroxyethyl starch 130/0.4 (90.2%). More MP4OX-treated patients experienced adverse events compared with controls (72.7% vs. 61.4%; P = 0.026). Transient elevations in laboratory values (e.g., alanine aminotransferase, aspartate aminotransferase, lipase, and troponin concentrations) occurred more frequently in the MP4OX group. There were no significant differences in the incidence of serious adverse events or in the composite morbidity and ischemia outcome end points, but nausea and hypertension were reported more often in MP4OX-treated patients.
Conclusion: MP4OX significantly reduced the incidence of hypotensive episodes in patients undergoing hip arthroplasty, but the adverse event profile does not support use in routine low-risk surgical patients for the indication evaluated in this study.
Source: PubMed