Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
ORal Antibiotics In Acute Mesenteric Ischemia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
ORal Antibiotics In Acute Mesenteric Ischemia a Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORIAMI
Brief Summary:
Acute mesenteric ischemia AMI is a life-threatening condition with an increasing incidence 7-13100000 PY The mortality of AMI is associated with the development and extent of transmural intestinal necrosis IN ranging from 25 without IN to 75 with IN Given its potential reversibility preventing the progression of AMI towards IN is now considered a primary therapeutic goal Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome Following the results of a pilot study showing an improvement in survival and lower resection rates our team created a first-of-its-kind intestinal stroke center SURVI unit Beaujon Hospital Clichy France that provides 247 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region As no randomized clinical trial has ever been conducted the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data AMI naturally progresses to sepsis surgical complications and multi-organ failure direct consequences of IN Features of sepsis are reported in up to 90 of AMI patients compared with 3-22 of patients with brain or myocardial ischemia supporting a specific septic component in AMI Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation In a prospective observational study the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation yielding a reduced occurrence of IN HR 016 95 confidence interval 003-062 However the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias
Detailed Description:
After the screening visit and informed consent collected by the recruiting investigator all consecutive eligible patients who will meet all inclusion criteria and none of exclusion criteria will be included and randomized double-blind to oral antibiotics or double placebo group
Patients will be evaluated at days 1 3 7 14 21 and 30 after the randomisation
Patients will be evaluated at days 1 3 7 14 21 and 30 after the randomisation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None