| CTRI Number |
CTRI/2024/06/069424 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
23/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate role of procalcitonin in detecting sepsis in patients with liver failure |
|
Scientific Title of Study
|
Spectrum of infections and efficacy of procalcitonin in detecting sepsis in
decompensated cirrhotic patients. |
| 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 |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
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 |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suriya KKN |
| Designation |
DM Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9597790222 |
| Fax |
|
| Email |
suriya5494@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| SuriyaKKN |
Manipal Academy of Higher Education |
Department of Gastroenterology and hepatology, kasturba medical college, manipal academy of higher education
Udupi
KARNATAKA |
9597790222
suriya5494@gmail.com |
|
|
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: K742||Hepatic fibrosis with hepatic sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Patients diagnosed with cirrhosis.
Patient with evidence of Systemic inflammatory response syndrome and presence of infection. |
|
| ExclusionCriteria |
| Details |
Patients diagnosed as Acute-on-chronic liver failure as per APASL definition.
Patients who are diagnosed with HCC |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the spectrum of various infections in patients with
decompensated cirrhosis.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of procalcitonin as a marker in detecting
sepsis in patients with decompensated cirrhosis. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
30/05/2025 |
| 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="0"
Months="6"
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
|
Patients who are diagnosed with decompensated cirrhosis after obtaining written informed consent and checking for exclusion criteria will be enrolled in the study. Information regarding relevant history, physical examination and laboratory parameters will be entered in a preformatted data sheet. Baseline severity scores such as the CTP, MELD Na and qSOFA will be calculated. Patients with suspected infections will be screened based on the clinical condition, laboratory parameters, radiological findings and culture reports. As per the protocol serum procalcitonin has been routinely used as a marker in all patients suspected of infections in our department. In these patients procalcitonin will be determined within the first 12 hours of admission. |