| CTRI Number |
CTRI/2024/07/070450 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An interventional trial to assess the efficacy of ulinastatin to reduce the number of days stayed in Intensive Care Unit and in the hospital for patients diagnosed with acute severe to moderately severe pancreatitis. |
|
Scientific Title of Study
|
Effect Of Ulinastatin As An Auxillary Drug In Reducing Mortality And Morbidity In Severe Acute Pancreatitis – A Randomised Control Open Labelled Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abishek Prasenaa A |
| Designation |
Postgraduate |
| Affiliation |
SRMMCH and RC Kattankulathur campus |
| Address |
Department of General Surgery
SRMMCH and RC
SRM Nagar
Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944450135 |
| Fax |
|
| Email |
ap7005@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Thinagaran K |
| Designation |
Professor and HOD |
| Affiliation |
SRMMCH and RC Kattankulathur campus |
| Address |
Department of General Surgery
SRMMCH and RC
SRM Nagar
Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9441074743 |
| Fax |
|
| Email |
hod.gensur.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abishek Prasenaa A |
| Designation |
Postgraduate |
| Affiliation |
SRMMCH and RC Kattankulathur campus |
| Address |
Department of General Surgery
SRMMCH and RC
SRM Nagar
Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9944450135 |
| Fax |
|
| Email |
ap7005@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery SRM Nagar Potheri Kattankulathur Kancheepuram district Tamil Nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRMMCH and RC Kattankulathur campus |
| Address |
Department of General Surgery SRM Nagar
Potheri
Kattankulathur
Kancheepuram district
Tamil Nadu
603203 |
| 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 Abishek Prasenaa A |
SRM Medical College Hospital and Research Centre Kattankulathur campus |
Departmeent of General Surgery
SRM Nagar
Potheri
Kattankulathur
603203
Kancheepuram
TAMIL NADU |
9944450135
ap7005@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K85||Acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Ulinastatin 200000 IU in 100ml ND/D5 IV BD for 5 days |
Inj Ulinastatin 200000 IU in 100ml ND/D5 IV BD for 5 days is given in addition to standard treatment as per IAP protocol |
| Comparator Agent |
standard treatment as per IAP protocol |
standard treatment as per IAP protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical Presentation: Presence of any two of the following three criteria:
A.Upper abdominal pain characteristic of acute pancreatitis (acute onset of persistent, severe, epigastric pain often radiating to the back).
B.Serum amylase and/or lipase levels three times the upper limit of normal (amylase: 40-140 units/litre, lipase: 0-160 units/litre).
C.Characteristic findings of acute pancreatitis on CT or ultrasonography.
2. Diagnosis of moderately severe or severe acute pancreatitis, based on the revised Atlanta classification for acute pancreatitis.
3. Post-ERCP (Endoscopic Retrograde Cholangiopancreatography) pancreatitis.
4. Pancreatitis with multiorgan dysfunction.
|
|
| ExclusionCriteria |
| Details |
1.Exclusion of cases with mild pancreatitis, defined by the absence of organ failure, local, or systemic complications.
2.Pregnancy or Nursing.
3.Recent Participation in Clinical Studies.
4.Pancreatic Cancer.
5.Non-Participation Willingness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the morbidity rate in form of abdominal pain and number of days stayed in hospital |
Assessed on day 0, day 3, day 28 or at discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce the case fatality rate |
Assessed from day 0 to day 28 or discharge & once at day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
16/07/2024 |
| Date of Study Completion (India) |
18/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After obtaining Institutional scientific committee and ethical committee clearance, CTRI
registration, informed consent written in their own language will be obtained from all the patients.
Patients found eligible
as per inclusion criteria were offered to participate in the study.
A proforma was filled
for each patient to record.
Patients will be randomized into two groups by
alloting random numbers
Group A: subjects in this group will receive
ulinastatin + standard treatment as per IAP protocol. Subjects in group a will receive ulinastatin
administered by iv infusion in a dose of 200,000 iu in 100ml of d5 or ns
administered over 1 hour twice daily (12 ± 2 hours apart) for 5 days (days 1 to
day 5). A minimum of 6 doses should have been administered to the subject to be
eligible for efficacy analysis.
Group B: subjects in this group will receive
only standard treatment as per IAP protocol. Various parameters including mortality rates, onset of new organ failure, local complications, ICU and hospital
stay, biomarker levels,
and pain scores were assessed to understand the
potential benefits of ulinastatin treatment compared to standard therapy alone
|