NCT04564638

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 11, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

4.5 years

First QC Date

September 11, 2020

Last Update Submit

September 21, 2020

Conditions

Ulcerative Colitis

Keywords

corticosteroids, cyclosporine, colectomy, clinical outcome

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Responce to Corticosteroid

    Responce to first intravenous corticosteroid was defined as no need for colectomy or rescue therapy within admission.

    Admission on index flare

Interventions

CorticosteroidDRUG
Also known as: cyclosporine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

IBD patients treated in hospital ward with first intravenous corticosteroid

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Adrenal Cortex HormonesCyclosporine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, specialist in internal medicine and gastroenterology

Study Record Dates

First Submitted

September 11, 2020

First Posted

September 25, 2020

Study Start

March 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 25, 2020

Record last verified: 2020-09