| CTRI Number |
CTRI/2024/01/061929 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of Oxford index, AIIMS index and ADMIT-ASC index to anticipate response to steroid in patients with acute severe ulcerative colitis |
|
Scientific Title of Study
|
Prospective comparison of Oxford index, AIIMS index and Admit-ASC index to predict steroid response in patients with acute severe ulcerative colitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mans Kumar Panigrahi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences, Bhubaneswar(Odisha)
Khordha
ORISSA
751019
India |
| Phone |
9861278332 |
| Fax |
|
| Email |
manaskumarpanigrahi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamlesh Ahari |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Gastroenterology, 2nd floor OPD building, All India Institute of Medical Sciences, Patrapada, SIjua Bhubaneswar(Odisha)
Khordha
ORISSA
751019
India |
| Phone |
9119184558 |
| Fax |
|
| Email |
aharikamlesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Ahari |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Gastroenterology, 2nd floor OPD building, All India Institute of Medical Sciences, Patrapada, Sijua Bhubaneswar(Odisha)
Khordha
ORISSA
751019
India |
| Phone |
9119184558 |
| Fax |
|
| Email |
aharikamlesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Bhubaneswar (ODISHA) |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kamlesh Ahari |
All India Institute of Medical Sciences, Bhubaneswar |
Department of Gastroenterology, 2nd floor, OPD building
All India Institute of Medical Sciences, Bhubaneswar (Odisha)
Khordha
ORISSA |
9119184558
aharikamlesh2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age ≥18 years
2. Patients presenting with a diagnosis of ASUC as
defined by Truelove and Witt’s criteria.
|
|
| ExclusionCriteria |
| Details |
1. Age ≤ 18 years
2. Patients who received IV steroids before
admission
3. Patients with CMV colitis
4. Patients with Crohn’s colitis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical accuracy of Oxford index, AIIMS INDEX and ADMIT-ASC index for prediction of steroid responsiveness on day 1 and day 3 in patients with ASUC |
January 2024 to October 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Differences in disease characteristics (duration, extent), prior treatment history & biochemical parameters(baseline hemoglobin, serum
albumin level) between steroid failure & steroid responders at day 7.
|
January 2024 to October 2025 |
| Difference in median CRP level & baseline fecal calprotectin level at day 1 & day 3 between steroid failure & steroid responders. |
January 2024 to October 2025 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute severe ulcerative colitis (ASUC) is a medical emergency diagnosed by Truelove and Witt’s criteria that require urgent hospitalization & aggressive management. Approximately 15-25% of patients with ulcerative colitis experience a severe flare during the course of their disease. Of these, consistent data have shown that 30–40% of patients will fail to respond to steroid therapy and require rescue therapy or urgent colectomy. The mortality associated with such attacks has fallen from levels of 31–61% to the present level of 1–2% following the introduction of high-dose corticosteroid therapy and the acceptance of a policy of early surgery in patients not responding to medical therapy. Oxford index, index and ADMIT-ASC index are needed to be compared prospectively for the best use to predict steroid responsiveness in patients with ASUC. So, this study will be aimed at prospective comparison of Oxford index, AIIMS index and ADMIT-ASC index to predict steroid response in patients with acute severe ulcerative colitis. |