A clinical trial to study the efficacy of intravenous albumin infusion along with corticosteroids and nutrition in patients with Acute Severe Ulcerative Colitis

INTERVENTION: Intervention1: Intravenous human albumin solution along with IV hydrocortisone and exclusive enteral nutrition: 20% w/v intravenous albumin solution (100 ml) i.e. 20 g/day which will be infused over 3‐4 hours for a total duration of 5 days Intravenous hydrocortisone 100 mg 6 hourly for 5 days Exclusive enteral nutrition for 7 days Control Intervention1: Iv hydrocortisone and exclusive enteral nutrition: Intravenous hydrocortisone 100 mg 6 hourly for 5 days Exclusive enteral nutrition for 7 days CONDITION: Health Condition 1: K50‐K52‐ Noninfective enteritis and colitis PRIMARY OUTCOME: 1) Proportion of patients with steroid failure in both the groups ; 2) Proportion of patients with treatment related adverse events in both the groups ; Timepoint: 1) Day 21 ; 2) Colectomy SECONDARY OUTCOME: 1) Response rates to IFX rescue therapy in both the groups, if iv steroids are failing ; 2) Changes in fecal calprotectin and serum CRP level after 3rd day of treatment in both the groups ; 3) Changes in ischemia modified albumin, albumin fractions (HMA, HNA1 and HNA2) and pro‐inflammatory cytokines at day 5 in both the groups ; 4) Duration of hospital stay in both the groups ; Timepoint: 1) Day 21 ; 2) Colectomy INCLUSION CRITERIA: 1) Patients with Acute Severe Ulcerative Colitis as defined by Truelove and Wittâ??s criteria 2) Patients giving written informed consent