None listed
Conditions
Brief summary
Double blinded randomized controlled trial (RCT) comparing administration of IV albumin versus placebo prior to rescue infliximab in Acute Severe Ulcerative Colitis (ASUC). We hypothesise that administration of intravenous albumin prior to rescue infliximab will increase serum albumin levels and the amount of IFX that is protein-bound, therefore reducing IFX clearance and increasing drug exposure and efficacy.
Interventions
Intravenous infusion of 2 x100mls concentrated albumin (20%)as single administration immediately prior to rescue infliximab (either 5mg/kg or 10mg/kg [if endoscopic mayo score 3 and CRP:Albumin ratio >1 at time of rescue]) versus placebo (saline)
Sponsors
Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed