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 Randomised Controlled Trial

• Published in: Journal of Crohn's and colitis 2024-11, Vol.18 (11), p.1870-1878
• Main Authors: Mundhra, Sandeep K, Madan, Divya, Golla, Rithvik, Sahu, Pabitra, Vuyyuru, Sudheer K, Kante, Bhaskar, Kumar, Peeyush, Mathew Thomas, David, Prasad, Shubham, Vaishnav, Manas, Verma, Mahak, Virmani, Shubi, Bajaj, Aditya, Markandey, Manasvani, Ranjan, Mukesh Kumar, Arora, Umang, Singh, Mukesh Kumar, Makharia, Govind K, Ahuja, Vineet, Kedia, Saurabh
• Format: Article
• Language: English
• Subjects: Acute Disease; Adult; Albumins - administration & dosage; Anti-Inflammatory Agents - administration & dosage; Colectomy - methods; Colitis, Ulcerative - drug therapy; Colitis, Ulcerative - therapy; Combined Modality Therapy - methods; Enteral Nutrition - methods; Female; Humans; Hydrocortisone - administration & dosage; Hydrocortisone - blood; Infusions, Intravenous; Male; Steroids - administration & dosage
• ISSN: 1873-9946; 1876-4479; 1876-4479
• DOI: 10.1093/ecco-jcc/jjae094

Abstract Introduction Overall, 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 antioxidant properties, might further improve steroid response in ASUC, which was evaluated in the present study. Methods In this open-label, randomised, controlled trial, patients with ASUC were randomised in 1:1 ratio to either albumin + standard of care [SOC] + EEN [Albumin arm] or SOC + EEN [SOC arm], over January 2021–February 2023. Both arms received 5 days of EEN with 400 mg IV hydrocortisone/day. Patients in the Albumin arm were administered 5 days of 20% weight/volume [w/v] intravenous albumin [100 ml]. Primary outcome was first, steroid failure [need for rescue medical therapy or colectomy] and second, proportion of patients with adverse events. Results In all, 61 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 arms (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 [interquartile range] duration of hospitalisation [10.5 [7-16] vs 10 [7-20], p = 0.43] were also comparable. The long-term composite outcome of colectomy and re-admission rates was numerically higher in the Albumin than the SOC arm [37.04% vs 17.86%, p > 0.05], although this 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.