Health Condition 1: K50-K52- Noninfective enteritis and colitis
Conditions
Interventions
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
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients with Acute Severe Ulcerative Colitis as defined by Truelove and Wittâ??s criteria 2) Patients giving written informed consent
Exclusion criteria
Exclusion criteria: 1) Age 75 years 2) Patients with indeterminate form of colitis or Crohnâ??s colitis 3) Patients with infection related flares 4) Patients with infective colitis or colitis of other etiologies 5) ASUC patients having toxic megacolon, paralytic ileus or perforation 6) Pregnancy 7) Patient who have received any dose of steroids or biologics for treatment of index episode before coming to this center 8) Other major co-morbid conditions like acute myocardial infarction, chronic kidney disease or chronic liver disease, congestive heart failure or acute kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactSandeep Kumar Mundhra
AIIMS
Outcome results
None listed