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 )

Study Overview

• Status: Not yet recruiting
• Conditions: Early Detection of Complication of Ulcerative Colitis

Detailed 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 Type: Observational
• Enrollment (Estimated): 95

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Pt above 18 years old presented with Acute severe ulcerative colitis treated by Iv steroid

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early prevention of complication of ulcerative colitis	Histopathology of colon biopsy	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Santos AL, Lopes S, Peixoto A, Garrido I, Medas R, Andrade P, Macedo G. The ACE (Albumin, CRP, and Endoscopy) Index in Acute Colitis: Simplify to a Better Prognostic Prediction. Inflamm Bowel Dis. 2021 Oct 20;27(11):e140. doi: 10.1093/ibd/izab189. No abstract available.

Helpful Links

• The ACE (Albumin, CRP and Endoscopy) Index in Acute Colitis: A Simple Clinical Index on Admission that Predicts Outcome in Patients With Acute Ulcerative Colitis

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Steroid in ulcerative colitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No