NCT Number: NCT06267651
Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals
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 )
Trial opening soon.
Get NotifiedKey information
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult Patients (≥18 years) known ulcerative colitis presented with activity .
2- newly diagnosed ulcerative colitis
Exclusion criteria
- 1) patient presented with CMV colitis 2) Clostridium difficile infection 3) Elective admission
Treatment and study plan
Primary outcomes
-
Early prevention of complication of ulcerative colitis
Time frame: 2 years
Histopathology of colon biopsy
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Feb 20, 2024
- Registry last updated
- Feb 20, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.