Suchergebnisse

Background Acute respiratory distress syndrome (ARDS) results in vascular leakage, inflammation and respiratory failure. There are currently no approved pharmacological treatments for ARDS and standard of care involves treatment of the underlying cause, and supportive care. The vascular leakage may be related to reduced concentrations of local adenosine, which is involved in maintaining endothelial barrier function. Interferon (IFN) beta-1a up-regulates the cell surface ecto-5′-nucleotidase cluster of differentiation 73 (CD73), which increases adenosine levels, and IFN beta-1 may, therefore, be a potential treatment for ARDS. In a phase I/II, open-label study in 37 patients with acute lung injury (ALI)/ARDS, recombinant human IFN beta-1a was well tolerated and mortality rates were significantly lower in treated than in control patients. Methods/design In this phase III, double-blind, randomized, parallel-group trial, the efficacy and safety of recombinant human IFN beta-1a (FP-1201-lyo) will be compared with placebo in adult patients with ARDS. Patients will be randomly assigned to receive 10 μg FP-1201-lyo or placebo administered intravenously once daily for 6 days and will be monitored for 28 days or until discharged from the intensive care unit. Follow-up visits will then take place at days 90, 180 and 360. The primary endpoint is a composite endpoint including any cause of death at 28 days and days free of mechanical ventilation within 28 days among survivors. Secondary endpoints include: all-cause mortality at 28, 90, 180 and 360 days; organ failure-free days; length of hospital stay; pharmacodynamic assessment including measurement of myxovirus resistance protein A concentrations; and measures of quality of life, respiratory and neurological function at 180 and 360 days. The estimated sample size to demonstrate a reduction in the primary outcome between groups from 30% to 15% is 300 patients, and the study will be conducted in 70–80 centers in nine countries across Europe. Discussion There are no effective specific treatments for patients with ARDS and mortality rates remain high. The results from this study will provide evidence regarding the efficacy of a potential new therapeutic agent, FP-1201-lyo, in improving the clinical course and outcome for patients with moderate/severe ARDS. Trial registration European Union Clinical Trials Register, no: 2014-005260-15 . Registered on 15 July 2017.

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances. These documents inform and shape patient care around the world. In this Perspective we discuss the importance of diversity on guideline panels ; the disproportionately low representation of women on critical care guideline panels, and existing initiatives to increase the representation of women in corporations, universities, and government. We propose five strategies to ensure gender parity within critical care medicine. ; American College of Emergency Physicians ; American Thoracic Society Assembly on Critical Care, Women in Critical Care Working Group ; American Thoracic Society-Health Equality and Diversity Committee ; Australia and New Zealand Intensive Care Society ; Canadian Critical Care Society ; Canadian Critical Care Trials Group ; German SepNet Critical Care Trials Group ; German Sepsis Society ; Global Sepsis Alliance ; International Forum for Acute Care Trialists (InFACT) ; Latin American Sepsis Institute ; Scandinavian Society of Anaesthesiology and Intensive Care Medicine ; George Institute for Global Health ; World Federation of Critical Care Nurses ; World Federation of Societies of Intensive and Critical Care Medicine ; Univ Toronto, Dept Med, Toronto, ON, Canada ; lnterdepartmental Div Crit Care Med, Toronto, ON, Canada ; Sinai Hlth Syst, Toronto, ON, Canada ; Univ Toronto, Lawrence S Bloomberg Fac Nursing, Toronto, ON, Canada ; Univ Toronto, Univ Hlth Network, Toronto, ON, Canada ; Canadian Crit Care Soc, Markham, ON, Canada ; St Michaels Hosp, lnterdepartmental Div Crit Care Med, Toronto, ON, Canada ; St Michaels Hosp, Dept Surg, Toronto, ON, Canada ; Li Ka Shing Knowledge Inst, Toronto, ON, Canada ; Univ Fed São Paulo, Anesthesiol Pain & Intens Care Dept, São Paulo, Brazil ; McMaster Univ, Hamilton Hlth Sci Thrombosis & Atherosclerosis Re, Hamilton, ON, Canada ; McMaster Univ, Dept Med, Hamilton, ON, Canada ; McMaster Univ, Clin Epidemiol & Biostat, Hamilton, ON, Canada ; McMaster Univ, Crit Care Med, Hamilton, ON, Canada ; Univ Calif San Francisco, Div Pulm Crit Care Allergy & Sleep Med, San Francisco, CA 94143 USA ; Univ Calif San Francisco, Cardiovasc Res Inst, San Francisco, CA USA ; Vanderbilt Univ, Sch Med, Dept Pathol Microbiol & Immunol, Nashville, TN 37212 USA ; Univ Colorado, Sch Med, Pulm Sci & Crit Care Med, Denver, CO USA ; Univ British Columbia, British Columbia Childrens Hosp, Dept Pediat, Vancouver, BC, Canada ; Univ Montreal, Hosp Ctr, Montreal, PQ, Canada ; Univ Montreal, Div Intens Care, Montreal, PQ, Canada ; George Inst Global Hlth, Div Crit Care & Trauma, Sydney, NSW, Australia ; Univ Sydney, Sydney, NSW, Australia ; Jena Univ Hosp, Ctr Sepsis Control & Care, Dept Anesthesiol & Intens Care, Jena, Germany ; Global Sepsis Alliance, Jena, Germany ; Imperial Coll London, Dept Paediat, Wellcome Trust Ctr Clin Trop Med, London, England ; Univ Vermont, Div Pulm & Crit Care Med, Burlington, VT USA ; Makerere Univ, Dept Anesthesia & Crit Care, Kampala, Uganda ; Inst Med Sci, Bombay Hosp, Dept Crit Care Med, Bombay, Maharashtra, India ; Univ Fattouma Bourguiba, Ctr Hosp, Monastir, Tunisia ; Oslo Univ Hosp, Scandinavian Soc Anaesthesiol & Intens Care Med, Oslo, Norway ; Oslo Univ Hosp, Dept Anaesthesiol, Oslo, Norway ; Tribhuvan Univ, Teaching Hosp, Dept Anaesthesiol, Kathmandu, Nepal ; Univ Fed São Paulo, Anesthesiol Pain & Intens Care Dept, São Paulo, Brazil ; Web of Science