Phase
Condition
Occlusions
Treatment
Placebo
Metronidazole
Gentamicin
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult patient aged 18 and less 90
AMI of arterial occlusive origin, defined by the combination of
Onset < 7 days of clinical, biological and/or radiological signs of acuteintestinal injury in the territory of at least superior mesenteric ischemia,including right-side colitis,
significant vascular obstruction > 75% of the superior mesenteric artery, and
no alternative diagnosis
- Admitted to the SURVI care network (Beaujon Hospital intensive care unit or SURVI,Bichat intensive care unit or vascular surgery department)
Exclusion
Exclusion Criteria:
Other forms of mesenteric ischemia (chronic without acute manifestations, venous,non-occlusive, strangulation, aortic dissection)
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 (palliativecontext)
Indication for an emergency surgical intestinal resection at the admission to theSURVI care network
Indication for urgent systemic antibiotic treatment on admission (evidence of sepsisdefined 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)
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 productor patient being in the exclusion period at the end of a previous study
Study Design
Study Description
Connect with a study center
Gastroentérologie-Hépatologie Beaujon
Clichy, 92110
FranceActive - Recruiting
Réanimation - Beaujon
Clichy, 92110
FranceActive - Recruiting
Chirurgie vasculaire
Paris, 75018
FranceSite Not Available
Réanimation Bichat
Paris, 75018
FranceSite Not Available
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