Concentrated Albumin Prior to Rescue Infliximab (CAPRI) in Acute Severe Ulcerative Colitis (ASUC)

Phase 2

• Conditions: lcerative colitis; Inflammatory Bowel Disease; Ulcerative colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12619001081101
• Lead Sponsor: Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

A)Inpatients with Acute Severe Ulcerative Colitis (ASUC)

B)Refractory to IV steroids, requiring rescue Infliximab (IFX), as defined by the Oxford index

C)Hypoalbuminaemia (serum albumin < 30 at time of IFX rescue)

D)Naïve to infliximab

Exclusion Criteria

1.Not fulfilling Truelove Witts Criteria for ASUC
2.Normal albumin level at time of IFX rescue
3.IV steroid responders
4.IBD-U which, during follow-up, is diagnosed as Crohn’s colitis
5.Prior IFX exposure
6.Positive stool for C.Difficile
7.Toxic megacolon

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Infliximab (Area under curve) following administration, with serial serum measurements of drug level post infusion[Every 12 hours following administration for initial 72 hours and then daily until discharge]

Secondary Outcome Measures

Name	Time	Method
Proportion of patients requiring a Colectomy as assessed by medical records[30 days post intervention and 90 days post intervention];Infliximab stool loss measured by collection of daily stool[7 days post intervention];Brambell (neonatal) receptor saturation measured by serum assay[7 days post intervention];Time to next infliximab infusion assessed by medical records[Time in days from administration of Albumin/placebo to next infliximab infusion];Time to CRP normalization measured by serial serum measurements[Time in days from 1st infusion of infliximab];Serum albumin change[Daily assessment following first infusion]