ORal Antibiotics in Acute Mesenteric Ischemia

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial, called "ORal Antibiotics in Acute Mesenteric Ischemia," is investigating the use of oral antibiotics to help patients with a serious condition known as acute mesenteric ischemia (AMI). AMI occurs when blood flow to the intestines is severely reduced, which can lead to serious complications and even death. The goal of this trial is to see if taking oral antibiotics can prevent further damage to the intestines and improve survival rates. The study is taking place at a specialized center in France that provides round-the-clock care for AMI patients.

To be eligible for the trial, participants must be adults aged 18 to 90 who have been diagnosed with AMI due to a blockage in the blood vessels supplying the intestines. Those who meet specific criteria, such as showing signs of intestinal injury and significant blood vessel obstruction, may be invited to join. If enrolled, participants can expect to receive care that includes the study medication (oral antibiotics) and regular monitoring by a team of healthcare professionals. It's important to note that while this study aims to improve outcomes for AMI, there are some exclusions, such as those who have certain other medical conditions or are unable to provide consent.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• 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 (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)
• • 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