Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)

NCT03907631 | Active Not Recruiting

• 1 other identifier: 259837
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 1

Brief Summary

Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic and laboratory data.

Conditions

Severe Ulcerative Colitis

Keywords

Rescue; Infliximab; Outcomes; Risk Stratification

Outcome Measures

Primary Outcomes (2)

• In Hospital Outcomes

  Response assessed by the following clinical care decisions based on binary outcomes: need for rescue therapy (yes = 1 or no =), need for accelerated induction (yes = 1 or no = 0), need for surgery during index admission (yes = 1 or no = 0)

  30 days

• Colectomy rates

  Proportion of patients needing colectomy

  30 days

Secondary Outcomes (2)

• Long-term response to medical management

  day 90 and 12 month time points

• Risk factors for need for rescue

  30

Study Arms (1)

Acute Severe Ulcerative Colitis

Patients hospitalised for acute severe ulcerative colitis will be invited to participate. Participants will be treated at the discretion of their treating physicians as per standard of care. We expect some participants will undergo an endoscopic assessment, some participants will be treated with standard versus accelerated infliximab dosing, permitting comparisons, in addition to other treatment strategies.

Other: Standard of care

Interventions

Standard of care OTHER

care decisions driven by local physicians; this is an observational cohort

Acute Severe Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised patients with Acute severe ulcerative colitis

You may qualify if:

• age 18 - 80 years.
• Confirmed acute severe ulcerative colitis based on modified Truelove and Witts criteria requiring hospital admission.
• Need for at least 2 days of intravenous steroids
• Able to sign consent

You may not qualify if:

• Crohn's disease
• Admission for elective colectomy
• Infective colitis confirmed on stool culture, assays for C. difficile or cytomegalovirus
• Pregnancy
• Inability to sign consent
• Prior colitis related surgery - pouch, stoma

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Gastroenterology, Hull Royal Infirmary, Hull University Teaaching Hospitals NHS Trust

Hull, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool and colonic biopsies will be collected

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: October 18, 2019
• Primary Completion: January 31, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

GB (1)