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CTRI Number  CTRI/2026/04/108272 [Registered on: 13/04/2026] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Use of a blood test (MDW) to detect and predict outcomes in patients with severe infection (sepsis) 
Scientific Title of Study   Monocyte Distribution Width as a Diagnostic and Prognostic Biomarker of Sepsis 
Trial Acronym  MDW-Sepsis Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAmeya Lathi 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India 576104

Udupi
KARNATAKA
576104
India 
Phone  9960794365  
Fax    
Email  ameylathi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrShreesha N 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India 576104

Udupi
KARNATAKA
576104
India 
Phone  7892882273  
Fax    
Email  shreesha.n@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DrAmeya Lathi 
Designation  Junior Resident  
Affiliation  Kasturba Medical College, Manipal 
Address  Department of General Medicine, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India 576104

Udupi
KARNATAKA
576104
India 
Phone  9960794365  
Fax    
Email  ameylathi@gmail.com  
 
Source of Monetary or Material Support  
Self-funded / Institutional support (Kasturba Medical College Manipal, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India) 
 
Primary Sponsor  
Name  KASTURBA MEDICAL COLLEGE 
Address  Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India 
Type of Sponsor  Private medical college 
 
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 
DrAmeya Lathi  Kasturba Hospital  Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka,576104, India
Udupi
KARNATAKA 
9960794365

ameylathi@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age more than 18 years
Patients admitted to ICU with suspected infection
Patients meeting Sepsis3 criteria 
 
ExclusionCriteria 
Details  Patients with hematological malignancies
Patients on immunosuppressive therapy
Refusal to consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic accuracy of Monocyte Distribution Width (MDW) in identifying sepsis  DAY 0 (AT ADMISSION)
DAY 3
DAY 5 
 
Secondary Outcome  
Outcome  TimePoints 
Prognostic value of MDW in predicting patient outcomes (survivors vs non-survivors)
Association of MDW with severity of illness
Correlation of MDW with inflammatory markers 
DAY 0 (AT ADMISSION)
DAY 3
DAY 5 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
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)   05/05/2026 
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="10"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ameylathi@gmail.com].

  6. For how long will this data be available start date provided 30-12-2027 and end date provided 30-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Sepsis is a major cause of morbidity and mortality among hospitalized patients, particularly in intensive care settings, where early diagnosis and risk stratification are critical for improving outcomes. Conventional diagnostic tools such as blood cultures and biomarkers like C-reactive protein and procalcitonin have limitations related to sensitivity, specificity, cost, and availability.

Monocyte Distribution Width (MDW) is a novel parameter derived from routine complete blood count that reflects monocyte morphological changes during systemic inflammation and infection. It is rapid, cost-effective, and does not require additional testing. Given that MDW is available as part of routine hematological analysis without additional cost or testing, it may serve as a practical alternative or adjunct biomarker in resource-limited settings.

This prospective cross-sectional observational study aims to evaluate the diagnostic accuracy of MDW in identifying sepsis and to assess its prognostic value in predicting disease severity and patient outcomes. The study will also examine the correlation of MDW with established inflammatory markers such as CRP, NLR, RDW, and procalcitonin.

MDW will be measured at admission and serially during hospitalization, and its performance will be analyzed in comparison to standard biomarkers. The findings of this study may support the use of MDW as an accessible and reliable biomarker for early diagnosis and prognostication of sepsis.
 
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