Health Condition 1: K519- Ulcerative colitis, unspecified
Conditions
Interventions
Intervention1: Intervention: â?¢ Inj hydrocortisone 100 mg iv 6 hrly.
â?¢ Semi-elemental EEN diet as per body weight per-oral or through NG tube
Control Intervention1: Control group: Semi-elemental
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients presented with Acute Severe Ulcerative Colitis as defined by Truelove and Wittâ??s criteria. 2.Patients who have not received any dose of steroid or other immune-suppressive therapy for this episode from outside. 3.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. UC patients with infection related flares (like CMV or C. difficile infection) 4. Patients with infective colitis or colitis of other etiologies. 5. ASUC patients having toxic megacolon, paralytic ileus or perforation. 6. Pregnancy 7. Other major co-morbid conditions like acute myocardial infarction, chronic kidney disease or chronic liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Proportion of patients requiring colectomy in both the groups. b) Proportion of patients requiring medical rescue therapy in both the groups c) Proportion of patients who have complete response and partial response to iv steroid on day 7 of treatment. Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Changes in fecal calprotectin and serum CRP level after 3rd day of treatment in both the groups. b) Changes in body weight, serum albumin level in both the groups at the end of follow up (Day 7) c) Treatment related adverse events in both the group. Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Pabitra Sahu
AIIMS
Outcome results
None listed