Long-term Outcome of Patients With Acute Ulcerative Colitis After First Course of Intravenous Corticosteroids

NCT ID: NCT04564638

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2019-09-01

Brief Summary

All episodes of patients with acute UC admitted to Tampere University Hospital and treated with intravenous corticosteroids between January 2007 and January 2016 were identified from patient records and reviewed. The risks for colectomy and for continuous use of corticosteroids were evaluated. Predictive factors were analysed.

Detailed Description

Data collected included epidemiological (gender, age at index flare, smoking status), clinical (UC duration, extent of the disease, prior Cs usage, disease severity, laboratory results at index flare) and treatment data (occurrence of new flares, need for further Cs therapy; CyA, thiopurines, biologics or colectomy during follow-up). The diagnosis of UC was made on basis of clinical history, symptoms, endoscopic and histological features. Disease extent was categorized by the Montreal classification and the severity of the flare was assessed by Mayo scoring system based on clinical and endoscopic characteristics. ASUC was characterized by more than six bloody stools/day along with any of the following: tachycardia, elevated temperature, anemia and/or ESR >30 mm/h (Truelove and Witt´s criteria)5. Alleviation of UC was defined as clinical response to intravenous corticosteroids with no need for colectomy or rescue therapy at the same hospitalization as the index flare. Relapse was defined as requiring further corticosteroid treatment, rehospitalization, rescue-therapy, or colectomy later in follow-up.

Conditions

Ulcerative Colitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

Corticosteroid

Intervention Type: DRUG

Other Intervention Names

cyclosporine

Eligibility Criteria

Inclusion Criteria

• Acute severe ulcerative colitis treated first time with iv corticosteroids
• Follow-up for at least six months after hospitalization or until colectomy.

Exlusion:

-Under 16 year of age

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heli T Eronen

MD, specialist in internal medicine and gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R15518S

Identifier Type: -

Identifier Source: org_study_id