World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 February 2021
Main ID:  NCT03942861
Date of registration: 25/04/2019
Prospective Registration: Yes
Primary sponsor: Copenhagen University Hospital at Herlev
Public title: Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. SUCCES
Scientific title: Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol.
Date of first enrolment: February 21, 2019
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03942861
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Denmark
Contacts
Name:     Johan F.K. Fremberg Ilvemark, MD
Address: 
Telephone: 0045 38686678
Email: jfre0079@regionh.dk
Affiliation: 
Name:     Johan F.K. Fremberg Ilvemark, MD
Address: 
Telephone: 0045 38686678
Email: jfre0079@regionh.dk
Affiliation: 
Name:     Jakob B. Seidelin, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Copenhagen University Hospital at Herlev
Key inclusion & exclusion criteria

Inclusion Criteria:

- Definitive diagnoses of Ulcerative colitis.

- Mayo clinical score =8.

- Need for Hospitalization and intravenous corticosteroid treatment.

- Age between 18-70.

- Ability and willingness to give written consent and comply with study protocol.

Exclusion Criteria:

- Contraindicators for infliximab.

- Bowel infection.

- Crohn's disease.

- Ultrasonographic inflammation in terminal ileum other than backwash ileitis.

- Bowel wall thickness <3 in Sigmoid colon.

- Minors.

- Known malignant disease.

- Pregnancy.

- Immune modulating therapy at admission apart from corticosteroids, mesalazine or
azathioprine.

Contraindicators = Patients suffering from moderate to severe heart failure,
hypersensitivity to murine proteins, severe bacterial infection.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Ultrasound Therapy; Complications
Intervention(s)
Drug: Solu-Medrol
Primary Outcome(s)
Changes in GIUS parameters 48 hours after intravenous corticosteroid treatment. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Secondary Outcome(s)
Calculate the best cutoff value for GIUS parameters for optimal sensitivity, specificity and accuracy compared to treatment outcome and endoscopy results. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Change in GIUS parameters correlation with change clinical scores and biochemistry on 48 ± 24 hours, 6 ± 1 days and after 3 months compared to baseline. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Change in GIUS parameters correlation with change in endoscopic scores and fecal calprotectin within 3 months compared to baseline. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Changes in GIUS parameters ability to predict treatment outcome. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
GIUS disease extent assessment compared to endoscopy and CT (if present). [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Interrater variability compared to central reading with regards to GIUS parameters. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Time since last meal correlated to feasibility of GIUS. [Time Frame: The outcome measure will be assessed after 18 months and reported within 36 months.]
Secondary ID(s)
CopenhagenUHH
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history