The SESAR investigator-initiated trial completes patient enrollment
Non-regulatory
Sedana Medical AB (publ) today announces that the enrollment of the planned 700 patients in the SESAR trial has been completed. The trial Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial (SESAR) is an investigator-initiated trial (IIT) that is supported in part by Sedana Medical and by the French Ministry of Health.
The SESAR trial, comparing sevoflurane via the Sedaconda ACD with intravenous propofol for up to 7 days is led by professor Matthieu Jabaudon and his team from Clermont Ferrand, France. The patient population consists of 700 adult patients with moderate to severe acute respiratory failure. The primary endpoint is ventilator-free days up to day 28 from randomization. Secondary endpoints include changes in pulmonary and other organ functions. The same research group published pilot study results in 2017, which led to this larger study, designed to corroborate the preliminary findings of the pilot.
“I am very happy that we have finally reached the enrollment target and I am very much looking forward to analyse the data and to see the results”, said professor Jabaudon. The work with data curation and analysis is expected to take at least until second half-year of 2024. Sedana Medical will not be involved in analysing the results.
“This is the largest clinical trial using the Sedaconda ACD, and on inhaled sedation in general, and the results are important. ICU sedation is challenging, especially in patients with ARDS. Any potential beneficial effects beyond sedation would make a new modality of sedation very attractive. Large trials, comparing outcomes after different sedative therapies may change the way patients are sedated during mechanical ventilation. We are very happy that the recruitment has been completed and are excited to learn about the outcomes”, said Peter Sackey, CMO of Sedana Medical.
References
Blondonnet et al. J Clin M 2022 May; 11(10): 2796. Design and Rationale of the Sevoflurane for Sedation in Acute Respiratory Distress Syndrome (SESAR) Randomized Controlled Trial.
Jabaudon M et al, Am J Respir Crit Care Med. 2017 Mar 15;195(6):792-800. Sevoflurane for Sedation in Acute Respiratory Distress Syndrome A Randomized Controlled Pilot Study
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
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About Sedana Medical
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.
Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden.