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CTRI Number  CTRI/2024/08/072884 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Study of Monocyte characteristics for early detection of infection in patients. 
Scientific Title of Study   Monocyte Distribution Width (MDW) as a useful indicator for early screening of sepsis and efficacy in screening patients with positive blood culture: A Prospective Observational study 
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 Priyanka mohapatra 
Designation  Senior resident 
Affiliation  Ruby Hall Clinic, Pune 
Address  Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  9777600155  
Fax    
Email  PRIYANKAMOHAP@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanmay Chaudhary 
Designation  Consultant 
Affiliation  Ruby Hall Clinic Pune 
Address  Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  9822058461  
Fax    
Email  dr.sanmay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Priyanka mohapatra 
Designation  Senior resident 
Affiliation  Ruby Hall Clinic Pune 
Address  Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra

Pune
MAHARASHTRA
411001
India 
Phone  9777600155  
Fax    
Email  PRIYANKAMOHAP@GMAIL.COM  
 
Source of Monetary or Material Support  
Ruby Hall Clinic, Sassoon road, Pune, Maharashtra, Pincode-411001  
 
Primary Sponsor  
Name  RUBY HALL CLINIC 
Address  Ruby Hall Clinic, Sassoon road, Pune, Maharashtra, Pincode-411001 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR PRIYANKA MOHAPATRA  RUBY HALL CLINIC  INTENSIVE CARE UNIT
Pune
MAHARASHTRA 
9777600155

PRIYANKAMOHAP@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE BIOMEDICAL AND HEALTH RESEARH POONA MEDICAL HEALTH RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Admitted in ICU in Ruby Hall clinic with suspicion of sepsis as defined by sepsis 3 criteria
2. Those whose complete blood count, blood culture and other lab tests will be sent within 12hours of admission 
 
ExclusionCriteria 
Details 
1. Patients with an inadequately low monocyte count (less than 100/μl)
2. Patients with a history of onco-haematological disease, immunocompromised, that could affect monocyte size and activation in response to infection.
3. Pregnant women
4. Patients admitted more than once to prevent duplication of data. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients will be grouped into blood culture positive and negative and Monocyte Distribution width, C-reactive protein (CRP), and Procalcitonin (PCT) value will be correlated with the blood culture and other cultures in all the groups.  within 2years 
 
Secondary Outcome  
Outcome  TimePoints 
Patient with above parameters like MDW, PCT, CRP and Neutrophil: lymphocyte ratio value will be correlated for each group and the significance of MDW in predicting sepsis.   within 2years 
-MDW efficacy in predicting sepsis in comparison to PCT and its variability in different group of patients.  within 2 years 
A follow-up of MDW, PCT, and CRP will be performed later in the course of sepsis among survivors and non-survivors to assess the prognostic value.   within 2 years 
-Using MDW as prognostication marker to see the length of ICU stay.  within 2years 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   01/09/2024 
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="2"
Months="0"
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  

 Monocytes can contribute to the process of inflammation or infection by secreting cytokines, however, there is increasing evidence that monocytes undergo morphological changes, including volume increase, during inflammatory or infectious processes and sepsis.

   Polilli et al compared patients with no sepsis, sepsis, and septic shock and found that MDW values were significantly higher in patients with sepsis or septic shock than in the no sepsis group.

    As MDW increases in response to bacterial infection in the blood, MDW is related to the blood culture results. Although the blood culture test is the gold standard in diagnosing bacterial infections in the blood, low sensitivity, and false positivity are still valid concerns


Patients to be admitted will be categorized into 3 groups: sepsis, probable sepsis, and control group according to sequential organ failure assessment (SOFA) criteria and Sepsis-3 criteria definitions. Institutions Sepsis Code activation in ER, will also be used as an enrolling tool in this study.


A control group will be taken comprising of patients with no evidence of infection like patients presenting to ICU with Cerebrovascular accident (CVA) without aspiration, class I (clean) post-operative care patients, and head trauma patients.

 All routine blood investigations will be sent including Complete Blood Count (CBC), MDW, and Procalcitonin (PCT), along with all other tests that could define infection, like imaging. 

Blood culture sensitivity (One set of aerobic and anaerobic/ Two sets of aerobic and anaerobic from two different sites if an invasive medical device is present) will be sent in all patients using all standard aseptic precautions. Other cultures will be sent as per the cause of sepsis suspicion.

 

 
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