| CTRI Number |
CTRI/2025/11/097472 [Registered on: 14/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between blood culture and serum procalcitonin. |
|
Scientific Title of Study
|
An observational study for association between serum procalcitonin level and positive blood culture in patients suspected of sepsis presenting to the emergency department of tertiary care hospital. |
| 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 Priyanshi |
| Designation |
DNB resident |
| Affiliation |
Medanta the Medicity |
| Address |
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Gurgaon
HARYANA
122001
India |
| Phone |
07988325349 |
| Fax |
|
| Email |
priyanshi.saini764@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Bansal |
| Designation |
Associate consultant |
| Affiliation |
Medanta the Medicity |
| Address |
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Gurgaon
HARYANA
122001
India |
| Phone |
8130893335 |
| Fax |
|
| Email |
Shrutibansalin@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanshi |
| Designation |
DNB resident |
| Affiliation |
Medanta the Medicity |
| Address |
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Gurgaon
HARYANA
122001
India |
| Phone |
07988325349 |
| Fax |
|
| Email |
priyanshi.saini764@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Priyanshi Saini |
| Address |
DNB resident Department of Emergency Medicine , Medanata the medicity Sector 38 Gurugram , Haryana Pin 122001 |
| Type of Sponsor |
Other [(primary investigator )] |
|
|
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 Priyanshi |
Medanta the Medicity |
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Department of Emergency Medicine , Medanta the Medicity , Sector 38 ,gurugram , haryana
Gurgaon
HARYANA |
07988325349
priyanshi.saini764@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
AGE GREATER THAN 18 YEARS OF AGE WHO ARE SUSPECTED OF BEING IN SEPSIS |
|
| ExclusionCriteria |
| Details |
AGE LESS THAN 18 YEARS
PATIENTS RECEIVED IV ANTIBIOTICS FOR 48 TO 72 HOURS IN HOSPITAL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| positive blood cultures |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICU requirement
vasopressors requirement
in hospital mortality rate |
time depends on patient condition |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
28/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This will be observational study to find out association between blood culture and serum procalcitonin levels in the patients suspected of being in sepsis presenting to emergency department of a tertiary care hospital of Northern India .
Aim of our study is to find out association of serum procalcitonin levels with that of positive blood cultures.
Primary objective of our study is association between blood culture and serum procalcitonin levels and secondary objective is specific serum procalcitonin cutoff value in culture positive bacterial sepsis |