P635 Intravenous albumin infusion does not augment the response rate to a combination of exclusive enteral nutrition and intravenous steroids in Acute Severe Ulcerative Colitis: a randomized controlled trial

Abstract Background 30-40% patients with acute severe ulcerative colitis (ASUC) fail intravenous (IV) steroids requiring medical rescue therapy/colectomy. Low baseline albumin predicts steroid non-response, and exclusive enteral nutrition (EEN) has been shown to improve steroid response and albumin levels. Albumin infusion due to its anti-inflammatory and anti-oxidant properties can further improve steroid response in ASUC, which was evaluated in present study. Methods In this open-label randomized controlled trial, patients with ASUC were randomized in 1:1 ratio to albumin + SOC + EEN vs. SOC + EEN (Jan2021 – Feb2023). Both arms received 5 days of EEN with 400 mg IV hydrocortisone/day. Patients in albumin arm were administered 5 days of 20% w/v intravenous albumin (100 ml). Primary outcome was steroid failure (need for rescue medical therapy or colectomy) and proportion of patients with adverse events. Results Sixty-one patients (albumin-30, SOC-31) (mean age-31.6 ± 10.4 years, male- 57.4%), were included. Baseline characteristics were comparable. There was no difference in steroid failure between albumin and SOC arm (10/30 (33.33 %) vs 13/31 (41.94 %), p=0.49). No adverse events were reported with albumin infusions. Colectomy rate (10 % vs 9.68 %, P=1), response to salvage medical therapy (88.89 % vs 76.92 %, P=0.62) and median duration of hospitalization (10.5 (7-16) vs 10 (7-20), P=0.43) were also comparable. Long-term composite outcome of colectomy and re-admission rates was numerically higher in the albumin than SOC arm (37.04 % vs 17.86 %), although it did not reach statistical significance. Conclusion There was no benefit of intravenous albumin infusion as an adjunct to IV steroids and EEN in patients with ASUC.