| CTRI Number |
CTRI/2024/02/062457 [Registered on: 08/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the role of prolactin in guiding antibiotic treatment in patients with severe acute pancreatitis |
|
Scientific Title of Study
|
Role of Procalcitonin in guiding antibiotic therapy in moderate to severe acute pancreatitis |
| 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 Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Department of gastroenterology and hepatology, kasturba medical college, MAHE, manipal, karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Department of gastroenterology and hepatology, kasturba medical college, MAHE, manipal, karnataka
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V S Mohammed Fazil |
| Designation |
DM Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of gastroenterology and hepatology,kasturba medical college, MAHE, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9985739786 |
| Fax |
|
| Email |
fazil.omc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal, karnataka, India - 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Ganesh Bhat |
Kasturba Medical College |
Department of Gastroenterology and Hepatology, Manipal academy of higher education, madhav nagar
Udupi
KARNATAKA |
9900791615
bhat.ganesh@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K869||Disease of pancreas, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the confirm diagnosis of moderate and severe acute pancreatitis |
|
| ExclusionCriteria |
| Details |
Admitted after 1 week of acute pancreatitis
Patient on antibiotic |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the procalcitonin level for Antibiotic usage during the admission period |
0,7,14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Profile of infection, intervention and outcome in moderate to severe acute pancreatitis |
0,7,14 days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
22/02/2024 |
| 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="5"
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
|
After obtaining written informed consent and checking for exclusion criteria ,patients with acute pancreatitis will be enrolled in the study on day 0 of acute pancreatitis. In brief, per protocol procalcitonin testing will be conducted on days 0, 7 ,14 and at any time before starting the antibiotics. The threshold for a positive procalcitonin test for this study is 1·0 ng/mL. Guidance is to start antibiotics following a test value of 1·0 ng/mL or more. Procalcitonin measurement-based guidance is one of a range of clinical considerations informing antibiotic management. In the enrolled patients, any empirical clinical decision to use antibiotics is preceded by measurement of procalcitonin. If the concentration is less than 1·0 ng/mL, antibiotics will not be used unless there is a clinically relevant positive microbiology result. Standard care followed the current International Association of Pancreatology/American Pancreatic Association guidelines for the management of patients with acute pancreatitis. |