%0 Journal Article
%T 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.
%A Mundhra SK
%A Madan D
%A Golla R
%A Sahu P
%A Vuyyuru SK
%A Kante B
%A Kumar P
%A Matthew D
%A Prasad S
%A Vaishnav M
%A Verma M
%A Virmani S
%A Bajaj A
%A Markandey M
%A Kumar Ranjan M
%A Arora U
%A Kumar Singh M
%A Makharia GK
%A Ahuja V
%A Kedia S
%J J Crohns Colitis
%V 0
%N 0
%D 2024 Jun 17
%M 38881153
%F 10.02
%R 10.1093/ecco-jcc/jjae094
%X <B>BACKGROUND: </B>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 might further improve steroid response in ASUC, which was evaluated in present study.<BR><B>METHODS: </B>In this open-label randomized controlled trial, patients with ASUC were randomized in 1:1 ratio to albumin + standard of care (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 1) steroid failure (need for rescue medical therapy or colectomy) and 2) proportion of patients with adverse events.<BR><B>RESULTS: </B>Sixty-one patients (albumin-30, SOC-31)(mean age-31.6±0.4 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%, p>0.05), although it did not reach statistical significance.<BR><B>CONCLUSIONS: </B>There was no benefit of intravenous albumin infusion as an adjunct to IV steroids and EEN in patients with ASUC.