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Clinical Trial Summary

1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis 2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups )


Clinical Trial Description

UlCerative colitis is characterized by mucosal inflammation initiating in the rectum and extending proximally in the colon in a continuous fashion. In patients with acute severe colitis, prompt hospital admission is required, A multidisciplinary approach is fundamental, and contacting a colorectal surgeon at the moment of admission is recommended. Sometimes, emergency surgery might be required early on in case of toxic megacolon, perforation or massive bleeding. Although treatment initiation should not be postponed in severe cases, excluding differential diagnoses, including C. difficile infection, is crucial. A limited flexible sigmoidoscopy without bowel preparation should be performed to assess disease severity .(1) aggressive medical therapy, starting with intravenous corticosteroids. Intravenous [IV] steroids remain the frst-line medical therapy for patients admitted with acute severe UC [ASUC], as defned by Truelove and Witts criteria,)(2) Almost one-third of patients, however, may not respond to IV steroids and go on to require second-line medical therapies [primarily infliximab or ciclosporin] or a colectomy . A signifcant body of research in recent years has focused on predicting outcome in patients with ASUC treated with IV steroids; ,(3) In 2022 the novel ACE was reported [Albumin, CRP, and Endoscopy] Index in acute colitis, which used biochemical and endoscopic parameters to predict steroid non-response on admission (albumin ≤ 30g/L [0 or 1] + C-reactive protein [CRP] ≥ 50 mg/L [0 or 1] + endoscopically severe according to physician's global assessment component of the Mayo score [0 or 1]), We can identify a high-risk subset of patients for targeted counselling and early administration of second-line therapy; this is particularly crucial as treatment delays are associated with increased mortality. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06267651
Study type Observational
Source Assiut University
Contact
Status Not yet recruiting
Phase
Start date January 2025
Completion date January 2027