ORal antibiotics In Acute Mesenteric Ischemia: a multicenter randomized - APHP220818

Assistance Publique Hopitaux De Paris0 个研究点目标入组 196 人开始时间: 2024年4月15日最近更新: 2024年8月21日

试验速览

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•Adult patient aged 18 and less 90, AMI of arterial occlusive origin, defined by the combination of 1) Onset < 7 days of clinical, biological and/or radiological signs of acute intestinal injury in the territory of at least superior mesenteric ischemia, including right-side colitis, 2) significant vascular obstruction > 75% of the superior mesenteric artery, and 3) no alternative diagnosis, Admitted to the SURVI care network (Beaujon Hospital intensive care unit or SURVI, Bichat intensive care unit or vascular surgery department)

•Other forms of mesenteric ischemia (chronic without acute manifestations, venous, non-occlusive, strangulation, aortic dissection), Unable to give consent (under guardianship or curatorship), Subject deprived of freedom, subject under a legal protective measure, Patient refusal to participate, Non-affiliation to a social security regimen or CMU, Patient under State Medical Aid, Pregnant or breastfeeding women, Participation in another clinical study involving investigational medicinal product or patient being in the exclusion period at the end of a previous study, Isolated left-side ischemic colitis, Mesenteric vascular lesion without small bowel injury or right colon, Not eligible for vascular or digestive surgery or intensive care (palliative context), Indication for an emergency surgical intestinal resection at the admission to the SURVI care network, Indication for urgent systemic antibiotic treatment on admission (evidence of sepsis defined as a SOFA score of 2 or more associated with an infection), Systemic or oral antibiotic therapy within 7 days before inclusion, Known hypersensitivity to the active substance /excipients, Contraindications to the investigational medicinal products (gentamicin, metronidazole)

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