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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564638
• Other study ID #: R15518S
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Corticosteroid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colectomy	We reviewed patient records for data on need for surgery within follow-up. We identified patients who had emergency colectomy and patients who needed surgery within 1 year of index flare or within follow-up.	Long-term follow-up. Years 2007-2016. Mean follow-up of 7.5 years.
Primary	Responce to Corticosteroid	Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.	Admission on index flare