| CTRI Number |
CTRI/2021/09/036689 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pentraxin-3 and Presepsin ki sepsis ke nidaan me upyogita |
|
Scientific Title of Study
|
Utility of Pentraxin-3 and Presepsin in prognosis of sepsis in critically ill patients |
| Trial Acronym |
3P in Sepsis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankur Sharma |
| Designation |
Associate Professor Trauma Emergency Anaesthesia |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesia and Critical Care
3rd Floor
IPD Block
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
BASNI PHASE2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Associate Professor Trauma Emergency Anaesthesia |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesia and Critical Care
3rd Floor
IPD Block
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
BASNI PHASE2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankur Sharma |
| Designation |
Associate Professor Trauma Emergency Anaesthesia |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anesthesia and Critical Care
3rd Floor
IPD Block
ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
BASNI PHASE2
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
AIIMS JODHPUR
BASNI PHASE 2
JODHPUR-342008
RAJASTHAN |
| Type of Sponsor |
Government medical college |
|
|
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 ANKUR SHARMA |
AIIMS JODHPUR |
AIIMS JODHPUR
BASNI PHASE2
JODHPUR 342005
Jodhpur
RAJASTHAN |
919654045653
ankuranaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5 ml whole blood will be taken from the patient |
5 ml whole blood will be taken from the patient for the purpose of serum procalcitonin estimation. The test for presepsin and PTX-3 will be done from the same sample |
| Comparator Agent |
5 ml whole blood will be taken from the patient |
5 ml whole blood will be taken from the patient for the purpose of serum procalcitonin estimation. The test for presepsin and PTX-3 will be done from the same sample |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients having clinical features suggestive of sepsis |
|
| ExclusionCriteria |
| Details |
Exclusion criteria are age < 18 years, patients with terminal stage of disease (malignant cancer of any type, acquired immunodeficiency syndrome, end-stage liver or renal disease) patient who have received antibiotics and patient/relatives who will not consent to inclusion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Changes in Pentraxin-3 and Presepsin levels in patients with sepsis during first week of ICU admission |
Day 1
3
7
death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the utility of Pentraxin-3 and Presepsin with prognosis of sepsis using sequential organ failure assessment (SOFA) score
2. To study the sensitivity and specificity of Pentraxin-3 and Presepsin for 28 day mortality in critically ill patients
3. To compare Pentraxin-3 and Presepsin with Procalcitonin in ICU patients with sepsis
|
Day 1
3
7
28
death or discharge |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sepsis is a clinical syndrome triggered by infection. While procalcitonin is used most common sepsis biomarker, its reliability is still an issue. Hence, we are planning to explore the utility of 2 new sepsis biomarkers, pentraxin-3 and presepsin. In this study, we will collect samples of these biomarkers on day 1, 3, 7, and at the time of discharge or death. We will correlate these biomarkers and their utility in the prognosis of patients with sepsis in ICU. |