| CTRI Number |
CTRI/2026/01/102238 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Postmorten needle biopsy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of organ injury in patients who die from severe infection in intensive care unit |
|
Scientific Title of Study
|
Clinicopathological Correlates of Sepsis-associated Organ Injury in a Tertiary-Care ICU: A Prospective Post-mortem Needle Biopsy 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 |
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 |
| 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 |
| 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 |
| 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 New Delhi |
| Address |
All India Institute of Medical Sciences (AIIMS), New Delhi- 110029, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Rahul Kumar Anand |
All India Institute of Medical Sciences |
Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS New Delhi- 110029.
South
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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
None |
None |
| Intervention |
Post mortem Biopsy |
Needle biopsy of organs namely lung, liver and kidney will be taken |
|
|
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 |
| Spectrum and severity of histopathological changes in lung, liver, and kidney in patients dying due to septic shock. |
Single time point — immediate post-mortem assessment, tissue obtained within 6 hours of death. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To relate histopathology severity to ante-mortem organ dysfunction
|
Ante-mortem clinical data collected during ICU stay; correlation performed with post-mortem histopathology assessed within 6 hours of death. |
| Parenchymal/epithelial injury grading |
Post-mortem histopathology assessed within 6 hours of death. |
| Describing the type of immune cells involved in terms of tissue invasion. |
Post-mortem histopathology assessed within 6 hours of death. |
| Exploratory outcomes (resource permitting)- To assess cell death, endothelial injury, thrombosis & markers of cell death by alternate pathway by immunohistochemistry (e.g., cleaved caspase-3; Complement C5b-9;syndecan-1; RIPK-1; ki67; PD-1 ) & examine their association with clinical severity. |
Post-mortem histopathology assessed within 6 hours of 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2026 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 - Clinical Study Report
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On request
- For how long will this data be available start date provided 02-02-2026 and end date provided 12-11-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a prospective post mortem observational study conducted in the Department of Anaesthesiology Pain Medicine and Critical Care at AIIMS New Delhi to study organ level injury patterns in sepsis and septic shock. The study includes adult patients who die in the intensive care unit due to severe sepsis or septic shock as defined by Sepsis 3 criteria and whose relatives provide written informed consent. Ultrasound guided post mortem core needle biopsies will be performed within six hours of death from liver lung and kidney using sterile technique. Two to three cores per organ will be fixed in 10 percent neutral buffered formalin processed into paraffin blocks and examined by experienced pathologists blinded to clinical data. Routine stains and organ specific special stains will be used to identify characteristic morphological changes. The primary outcome is to describe the spectrum of histopathological lesions in these organs among patients dying of septic shock. Secondary objectives include correlation of histopathology severity with ante mortem organ dysfunction grading of parenchymal and epithelial injury and identification of immune cell infiltration patterns. Exploratory analysis subject to resources will include immunohistochemistry for selected markers of cell death endothelial injury complement activation regeneration and immune exhaustion such as cleaved caspase 3 complement C5b 9 syndecan 1 RIPK1 ki67 and PD1. Findings will be correlated with clinical and laboratory parameters to improve understanding of sepsis related multi organ injury and provide a tissue level framework for future translational biomarker research in critical illness. |