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CTRI Number  CTRI/2026/03/106226 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Diagnostic 
Study Design  Other 
Public Title of Study
Modification(s)  		 Study of organ damage in ICU patients with severe infection (sepsis) using blood tests before death and tissue samples collected shortly after death 
Scientific Title of Study   Clinicopathologic and Biomarker Correlates of Sepsis-Associated Organ Injury: A Prospective Perimortem Study from a Tertiary-Care ICU 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Kumar Anand 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) New Delhi  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi- 110029. South DELHI 110029 India

South
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  rahulanand00@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Rahul Kumar Anand 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) New Delhi  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi- 110029. South DELHI 110029 India

South
DELHI
110029
India 
Phone  9013082271  
Fax    
Email  rahulanand00@gmail.com   
 
Details of Contact Person
Public Query  
Name  Siddhavivek Majage 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences (AIIMS) New Delhi  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi- 110029. South DELHI 110029 India

South
DELHI
110029
India 
Phone  6361237270  
Fax    
Email  sdmkvb@gmail.com   
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), New Delhi-110029, India.  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences AIIMS 
Address  All India Institute of Medical Sciences (AIIMS), New Delhi- 110029, India.  
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 Rahul Kumar Anand   All India Institute of Medical Sciences   Room number 5011, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi- 110029. India
South
DELHI 		 9013082271

rahulanand00@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Antemortem blood biomarkers and Post mortem Biopsy   A single blood sample will be collected in last 24 hours before death. Ultrasound-guided needle biopsy of the lung, liver, and kidney will be performed once after death for research purposes. The procedure will be completed in a single session lasting approximately 25–30 minutes. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Adult patients above 18 years dying in ICU due to septic shock as per Sepsis 3 criteria
2 Relatives provide written informed consent for post mortem needle biopsy
 
 
ExclusionCriteria 
Details  1 Family refusal to consent
2 Pre existing chronic lung disease
3 Pre existing chronic liver disease
4 Pre existing chronic kidney disease
5 Shock of any other cause
6 Time elapsed since death more than 6 hours

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the relationship between circulating biomarkers of necroptosis (RIPK3) and immune-checkpoint activation (soluble PD-L1) with their corresponding tissue expression patterns in patients who die of sepsis or septic shock in a tertiary-care ICU.  Blood biomarkers (RIPK3 and soluble PD-L1) will be measured once using a blood sample collected within the last 24 hours before death. Histopathological assessment of organ tissue will be performed on samples obtained within 6 hours after death.Post-mortem tissue biomarkers and histopathology will be assessed within 6 hours after death. 
 
Secondary Outcome  
Outcome  TimePoints 
2. Assess post-mortem tissue expression of RIPK1/MLKL, PD-L1 in liver, lung, & kidney using immunohistochemistry on formalin-fixed, paraffin-embedded (FFPE) biopsy samples.  Once, using tissue samples obtained within 6 hours after death. 
3. Correlate circulating biomarker levels with corresponding tissue IHC scores to determine whether blood levels reflect tissue activation states.  Once, using blood samples collected within the last 24 hours before death & tissue samples obtained within 6 hours after death. 
4. Examine associations between biomarker levels (plasma & tissue) & ante-mortem clinical indices of organ dysfunction (SOFA components, vasopressor dose, P/F ratio, creatinine, bilirubin).  Clinical indices assessed during stay & biomarkers from sample taken during the last 24 hours before death. 
5. Explore phenotypes by cross-classifying patients into biomarker clusters:
a. High-RIPK3 / High-sPD-L1 (hyper-inflammatory + immune-exhausted),
b. High-RIPK3 / Low-sPD-L1 (predominantly necroptotic),
c. Low-RIPK3 / High-sPD-L1 (predominantly immunosuppressed),
d. Low-RIPK3 / Low-sPD-L1 (resolving phenotype)
 		 Once, using blood samples collected within the last 24 hours before death. 
1. Quantify plasma concentrations of RIPK3 & soluble PD-L1 in sepsis decedents performed on pre-mortem blood samples  Once, using blood samples collected within the last 24 hours before death. 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   24/03/2026 
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="6"
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 - 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 - None of the above

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On request

  6. For how long will this data be available start date provided 01-06-2028 and end date provided 30-11-2031?
    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
Modification(s)  

Adult ICU patients (>18 years) diagnosed with severe sepsis or septic shock will be screened. After obtaining consent from the relatives, blood samples wll be obtained within 24 hours prior to death and will be analyzed for soluble biomarkers of immune exhaustion (sPD-1) and necroptosis (sRIPK3). Additionally, immunohistochemistry will be performed for key biomarkers representing mechanistic pathways—endothelial injury (Syndecan-1), complement activation (C5b-9), apoptosis (Caspase-3), necroptosis (RIPK1/MLKL), regeneration (Ki-67), immune exhaustion (PD-1/PD-L1), and neutrophil extracellular traps (H3Cit ± MPO). 

Ultrasound-guided core-needle biopsies of the liver, lung (non-dependent segment), and kidney will be performed within six hours of death using a sterile, disposable 14–18 G Tru-Cut needle under full biosafety precautions. Two to three cores will be obtained from each organ and immediately placed in 10 % neutral-buffered formalin, fixed for 24 hours, and processed into formalin-fixed, paraffin-embedded (FFPE) blocks. Routine H&E and appropriate special stains (PAS, MT, VVG, Reticulin, Perl’s, MSB) will be performed. Histopathological assessment will be carried out by pathologists blinded to clinical details.


All tissue and serum biomarker findings will be semiquantitatively graded or quantified, as applicable, and correlated with ante-mortem clinical and biochemical parameters of organ dysfunction.

 

 
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