Skip to main content
OpenTrials
Not Yet Recruiting

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 )

Not Yet Recruiting

Trial opening soon.

Get Notified

Key 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

  1. 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.