FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/094788 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Studying blood markers in sepsis patients to improve diagnosis and treatment 
Scientific Title of Study   Exploring the Differential Immune Responses in Community-Acquired Sepsis through Plasma Mediators and Immune Cell Analysis 
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 Chiranjay Mukhopadhyay 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, Kasturba Medical College, Manipal, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay.m@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Anusree A 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, Kasturba Medical College, Manipal, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9947713619  
Fax    
Email  anusree.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Public Query  
Name  Anusree A 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, Kasturba Medical College, Manipal, Madhav Nagar, Manipal, Udupi, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9947713619  
Fax    
Email  anusree.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education, Manipal 
Address  Department of Microbiology, 2nd floor, Basic Sciences building, Madhavnagar, Manipal 576104  
Type of Sponsor  Research institution and hospital 
 
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 Chiranjay Mukhopadhyay  Kasturba Medical College  Department of Microbiology,Kasturba Medical College, Manipal, Madhav Nagar, Manipal, 576104
Udupi
KARNATAKA 		 9845513057

chiranjay.m@manipal.edu 
 
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 
Healthy Human Volunteers  Age and sex matched individuals and not admitted to hospital or those with well controlled underlying conditions 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patient Group
1. Adult patients (age 18 and above) admitted to the ICUs with sepsis, shock and other inflammatory conditions like trauma, poisoning, pancreatitis.
2. SOFA score greater than 2

Healthy Controls
1. Healthy adults (18 years and above) not admitted to the hospital or those with well-controlled underlying conditions (hypertension, diabetes etc.)
2. Able and willing to provide the informed consent. 
 
ExclusionCriteria 
Details  Patient group
1. Age less than 18 years
2. Pregnant or breast-feeding women
3. Confirmed viral, fungal, parasitic, polymicrobial infections.
4. Patients with a withdrawal of care decision at time of inclusion
5. Patients whose anticipated duration of hospitalisation in ICU is estimated less than 48 hours.
6. Patient with restricted liberty or under legal protection
7. Expected lifespan less than 3 months due to pre-existing co-morbidities
8. Blood transfusion greater than 4 units in past week
9. Second admission to ICU or previous enrolment in study (within same hospital admission)
Transfer from other hospital ICU

Healthy Controls
1. Age less than 18 years
2. Pregnant or breast-feeding
2. Infected with any infectious diseases
3. Hemophilia, severe coagulation disorders or impaired venous access
4. Prolonged antibiotic usage in the last 3 months
5. History of sepsis/septic shock in the last 6 months  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of plasma and immune cell mediators with 28 day mortality  Three time points from ICU admission to 28 day follow up 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   03/10/2025 
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="3"
Months="0"
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [anusree.kmcmpl2024@learner.manipal.edu].

  6. For how long will this data be available start date provided 03-10-2026 and end date provided 03-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  
Sepsis remains a major global health burden with high mortality and limited therapeutic options beyond supportive care. The current treatment approaches often fail to save sepsis patients, highlighting the urgent need to deepen our understanding of the immune system’s role in the disease. Advancing immune research could enable the development of novel, targeted therapies that potentially reduce healthcare costs, save and improve the quality of millions of lives. Today, supportive interventions including quick antibiotic delivery, efficient source control, and organ support are crucial to the therapy of sepsis. Despite their need, these tactics frequently fail to increase survival because they ignore immunological dysregulation, which is crucial to the development of sepsis. Identifying subgroups and various endotypes within patients with distinctive immune profiles will provide chances for focused treatment approaches.  
This study aims to characterize the immune profiles of patients with community-acquired sepsis, to understand the temporal changes in immune response and identify distinct immunological patterns that may benefit from precision interventions. This is a prospective, observational study enrolling patients with community-acquired sepsis from a tertiary care hospital in South India. Peripheral blood samples will be collected from the critically ill patients with sepsis and sterile inflammation at three time points. Healthy individuals will also be recruited for the baseline establishment. Clinical and demographic data will be collected from all the recruited study subjects. Plasma cytokine and chemokine levels will be analyzed using Luminex multiplex assays to profile dynamic changes in immune parameters. Immune cell populations, including T cells, B cells, NK cells, and monocytes, will be quantified from isolated PBMCs using flow cytometry, with a focus on temporal variations and group-specific immune patterns. Identifying distinct immune signatures and temporal patterns in sepsis will enhance our understanding of disease heterogeneity and support the development of stratified immunomodulatory therapies.  
 
Close