Health Condition 1: K518- Other ulcerative colitis
Conditions
Interventions
Intervention1: Oral corticosteroids: Equivalent dose of oral corticosteroids (80mg/d) will be given for 3-6 days to the intervention arm compared to IV corticosteroids (60mg/d) in the standard arm
Con
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed cases of UC by endoscopy and biopsy 2. Patients with acute severe ulcerative colitis
Exclusion criteria
Exclusion criteria: 1. Patients with Hb less than 8g/dl 2. Patients with serum albumin levels less than 2.5 g/dl 3. Patients with sepsis precluding the use of corticosteroids with any two of the three criteria Fever Temp more than 100 F, TLC less than 4000/cumm or more than 12000/cumm, raised procalcitonin (more than 1 pg/dL) 4. Patients having more than 10 blood mixed stools 5. Patients having megacolon or toxic megacolon on abdominal x-ray 6. Patients with abdominal tenderness or features of impending perforation 7. Patients who have had any flare requiring corticosteroids in the preceding 3 months from inclusion 8. Patients with prior history of failure of response to intravenous corticosteroids for severe flare of ulcerative colitis 9. Patients already receiving oral corticosteroid at the time of inclusion 10. Patient who have received more than 1 dose of IV Corticosteroid during index admission 11. Poor performance status (ECOG 3) 12. Patients with suspected or proven malignancy of any organ and GI malignancy 13. Inclusion any other drug trial in last 03 months affecting outcome of current trial 14. Not willing to participate in the trial and sign the informed consent 15. Pregnant and lactating females 16. Patients with prior colonic surgery due to any cause.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission (defined as stool frequency less than or equal to 3 with no blood)Timepoint: Day 3 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal side effects of steroidTimepoint: Index admission;Number of subjects achieving Partial responseTimepoint: day 3;Requirement of second line medical therapy in both the groupsTimepoint: 3 months;Requirement of second line medical therapy in both the groups during the initial admissionTimepoint: During index admission;Requirement of surgeryTimepoint: 3 months;Requirement of surgery during the initial admissionTimepoint: During index admission;Total hospital stayTimepoint: During index admission | — |
Countries
India
Contacts
Public ContactRitesh Acharya
PGIMER, Chandigarh
Outcome results
None listed