| CTRI Number |
CTRI/2025/06/089374 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
To see whether patients blood count and peripheral smear can diagnose severe infections and compare with other tests like procalcitonin. |
|
Scientific Title of Study
|
Comparison of complete blood count and peripheral smear with procalcitonin and C reactive protein in diagnosis and prognostication of community acquired bacterial sepsis: A multicenter study in lower-middle income country |
| 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 Ruchi Gupta |
| Designation |
Consultant |
| Affiliation |
Holy Family Hopsital |
| Address |
Department of Critical Care Medicine, Holy Family Hospital, Okhla, New Delhi, Delhi
South
DELHI
110025
India |
| Phone |
9910695602 |
| Fax |
|
| Email |
ruchi_gupta.mamc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Consultant |
| Affiliation |
Holy Family Hopsital |
| Address |
Department of Critical care Medicine. Holy Family Hospital, Okhla, New Delhi, Delhi
South
DELHI
110025
India |
| Phone |
9910695602 |
| Fax |
|
| Email |
ruchi_gupta.mamc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Ray |
| Designation |
Medical Director & Head of the DepartmentConsultant |
| Affiliation |
Holy Family Hopsital |
| Address |
Department of Critical Care Medicine, Holy Family Hospital, Okhla, New Delhi, Delhi
Holy Family Hospital
South
DELHI
110025
India |
| Phone |
09810614433 |
| Fax |
|
| Email |
drsray67@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| European Society of Intensive Care Medicine.
Rue Belliard-19,
Postal code B-1040, Brussels, Belgium, Europe |
|
|
Primary Sponsor
|
| Name |
Dr Ruchi Gupta |
| Address |
Consultant, Department of Critical Care Medicine, Holy Family Hospital, Okhla, New Delhi, pincode 110025
Okhla, Delhi 110065 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Gupta |
Holy Family Hospital |
Department of Critical Care Medicine, Holy Family Hospital, Okhla, New Delhi, Delhi-110025, India
South
DELHI |
9910695602
ruchi_gupta.mamc@yahoo.co.in |
| Dr Niraj Tyagi |
Sir Ganga Ram Hospital |
Department of Critical Medicine, Old Rajinder Nagar, New Delhi-110060, India
Central
DELHI |
9810427121
niraj10dr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee Sir Ganga Ram Hospital |
Submittted/Under Review |
| Holy Family Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bacterial sepsis (S SIRS) |
S-SIRS: meeting ≥2 SIRS criteria and sepsis3.0 definition with well defined bacterial etiology (e.g. intra abdominal infections, Lobar consolidation, urosepsis, Skin and soft tissue infection like necrotising fascitis, puerperal sepsis and other defined bacterial sepsis based on clinical presentation or positive culture report.
|
| Intervention |
C reactive protein (CRP) |
Blood sample for CRP obtained within 2hrs of presentation.
CRP done by Standardized immunoassay |
| Intervention |
Complete blood count (CBC) and peripheral smear (PS)
Complete Blood count will include Hemoglobin (Hb), Platelet count (PC), Total Leucocyte Count (TLC), Differential leucocyte count (DLC) that includes Neutrophils(N), Lymphocytes(L), Eosinophils (E), Basophils (B) and Monocytes (M); and relevant ratios
Peripheral smear analysis will be done for Band cells, Myelocytes (My), Metamyleocytes (MMy), Toxic granulations (TG), Cytoplasmic Vacuolisation (CV) and Dohle Bodies (D).
Blood sample obtained within 2hrs of presentation
|
Hb, TLC, DLC, Platelet Count, band cells, myelocytes, metamyelocytes,Toxic granules, cytoplasmic vacuolisation, Dohle bodies, Relevant Ratios. Blood Sample obtained within 2hrs of admission and repeated on 4th day of admission. |
| Comparator Agent |
Non Inflammatory Systemic Inflammatory Response Syndrome (NI-SIRS) |
NI-SIRS: patients meeting ≥2 SIRS criteria at admission having one of following:
1. Acute pancreatitis within 48hrs of symptom onset.
2. Acute trauma within 48hrs of trauma.
|
| Intervention |
Procalcitonin (PCT) |
Blood sample obtained within 2hrs of presentation and analysed using BRAHMS PCT analysis |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient presenting to ICU with community acquired bacterial sepis from ER or hospital stay less than 24hrs meeting more than or equal to 2 SIRS criteria will be evaluated for inclusion into bacterial sepsis (S-SIRS) or NI- SIRS group. 2.Unconfirmed etiologies of SIRS will be included in the study subject in case of positive culture reports. |
|
| ExclusionCriteria |
| Details |
1.Hospitalization in last 3 months
2.Immediate post-operative status
3.Pregnancy
4.Immunosuppressants
5.Immunocompromised states like AIDS
6.Immune-deficiency disorders
7.Haematological malignancies
8.Patients with known or suspected non-bacterial causes of SIRS like fungal, viral, rickettsial, and parasitic infections.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare to diagnostic accuracy of components of CBC-PS (Hb, PC, TLC, DLC, Bn, My, MMy, TG, and D; and relevant ratios) with PCT and CRP in bacterial sepsis and non-infective SIRS. |
Within 2 hours of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the combination of components of CBC-PS differentiating bacterial
sepTo calculate the correlation coefficient of components of CBC-PS with APACHE II and compare it with PCT and CRP in patients of bacterial sepsis from NI-SIRS.
|
Within 2 hours of admission |
| To compare CBC-PS with Procalcitonin and CRP on day 1 and day 4 of admission in predicting 30-day mortality in patients of bacterial sepsis. |
30 day of admission |
| To evaluate correlation of CBC-PS with severity (APACHE And SOFA) of illness and compare it with PCT and CRP in patients of bacterial sepsis |
Admission (Day1) and on day 4 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/07/2025 |
| 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="1"
Months="6"
Days="1" |
|
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
|
Comparison of components complete blood count and peripheral smear with procalcitonin and C- reactive protein in diagnosis and prognostication of community acquired bacterial sepsis. It is a multi centre study to be conducted in lower middle income country (India). Prospective paired design cohort analysis to be carried in multi speciality in ICU of two tertiary care hospital in LMIC in patients aged 16-85 years over 18 months with sample size of 200 patients. Objectives:To Compare diagnostic accuracy of components of CBC -PS with PCT and CRP in bacterial sepsis and non infective SIRS. To analyse the combination of components of CBC-PS for differentiating bacterial sepsis from NI-SIRS To compare CBC-PS with procalcitonin and CRP on day 1 and day 4 of admission in predicting 30 day mortality in patients with Bacterial sepsis. To evaluate correlation of CBC-PS with severity of illness and compare it with PCT and CRP in patients with bacterial sepsis. Outcome- To compare the sensitivity and specificity of CBC-PS components with PCT and CRP in Bacterial sepsis and NI-SIRS.
|