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Regulation Approvals. Credit: Baxter. The EUA status allows Oxiris filter set to treat patients who have confirmed COVID, as well as admitted in the intensive care unit ICU with confirmed or imminent respiratory failure and require blood purification therapy to minimise pro-inflammatory cytokine levels, including application in continuous renal replacement therapy CRRT.
Oxiris is claimed to be the only filter set available in the US, which can be used to conduct multiple blood purification therapies simultaneously, including CRRT and cytokine removal. Oxiris does not need the use of a second CRRT filter or adsorber compared to other products, enabling to conserve energy. Baxter said that it will begin a small initial shipment of Oxiris immediately and focuses on significantly increasing the production within short time. Oxiris offers a new tool in the COVID fight while supplementing our overall supply of filters for blood purification therapies.
NS Medical Devices is using cookies We use them to give you the best experience. Its presence is even considered a factor with an independent association with mortality and has a higher fatality rate than ARF developed by another etiology. Different clinical studies have been developed based on the addition of hemoadsorption membranes to RRT that, although they have not shown significant differences in the reduction of mortality, have impacted secondary outcomes such as the reduction of pro-inflammatory cytokines, decrease in vasopressor support requirements, decrease in serum lactate, significant improvement in the SOFA score, improvement in oxygenation indices and decrease in hospital stay.
These benefits are presented without reports of adverse events associated with its use. The experience of its use is limited to in vitro studies, case reports, retrospective cohorts and an RCT that provide consistent evidence of its benefits. A longitudinal, bi-directional, observational analytical study is proposed. SA-AKI , as well as the dose of vasopressor support, oxygenation parameters and inflammatory markers. Hemodynamic and ventilatory parameters will be monitored every 24 hours, and inflammatory parameters every 48 hours.
A follow-up will be done at 28 days to establish mortality. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Criteria Inclusion Criteria:. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms.
Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : November 30, See Contacts and Locations. View this study on Beta. Study Description. FDA Resources. Outcome Measures. The parameters used in renal replacement therapy anticoagulation, duration and time to start in days will be taken from the electronic medical record.
Baxter said that it will begin a small initial shipment of Oxiris immediately and focuses on significantly increasing the production within short time. Oxiris offers a new tool in the COVID fight while supplementing our overall supply of filters for blood purification therapies. NS Medical Devices is using cookies We use them to give you the best experience. Continue Learn More X. Home » Regulation » Company News. Remember me. Don't have an account? Oxiris filter is suitable to conduct multiple blood purification therapies simultaneously Oxiris is claimed to be the only filter set available in the US, which can be used to conduct multiple blood purification therapies simultaneously, including CRRT and cytokine removal.
Recruitment status was: Recruiting First Posted : April 16, Last Update Posted : May 2, View this study on Beta. Study Description. The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.
Detailed Description:. Hemodynamic monitoring with dynamic parameters Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation and Echocardiography Indirect Calorimetry before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin , Endotoxin , Lactate, diuresis, tromboelastography post filter and arterial sample and dosage of Plasminogen Activator Inhibitor -1 at the same sites.
FDA Resources. Continuous Renal Replacement Therapy with oXiris filter. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. No resolution of the surgical source of infection Terminal condition Any contraindication to heparin and other anticoagulant. Other pathological conditions in which the oXiris filter is not indicated and other therapeutic options are required. Hepatic failure , Cardiac failure.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp. Blood Purif. Epub Apr National Library of Medicine U.