| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ameylathi@gmail.com].
- 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.
- 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. |