Study of organ injury in patients who die from severe infection in intensive care unit

Clinicopathological Correlates of Sepsis-associated Organ Injury in a Tertiary-Care ICU: A Prospective Post-mortem Needle Biopsy Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102238

Enrollment

Registered

2026-01-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Post mortem Biopsy: Needle biopsy of organs namely lung, liver and kidney will be taken Control Intervention1: None: None

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Spectrum and severity of histopathological changes in lung, liver, and kidney in patients dying due to septic shock.Timepoint: Single time point immediate post-mortem assessment, tissue obtained within 6 hours of death.	—

Secondary

Measure	Time frame
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.Timepoint: Post-mortem histopathology assessed within 6 hours of death.;To relate histopathology severity to ante-mortem organ dysfunction Timepoint: Ante-mortem clinical data collected during ICU stay; correlation performed with post-mortem histopathology assessed within 6 hours of death.;Parenchymal/epithelial injury gradingTimepoint: Post-mortem histopathology assessed within 6 hours of death.;Describing the type of immune cells involved in terms of tissue invasion.Timepoint: Post-mortem histopathology assessed within 6 hours of death.	—

Measure

Time frame

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.Timepoint: Post-mortem histopathology assessed within 6 hours of death.;To relate histopathology severity to ante-mortem organ dysfunction Timepoint: Ante-mortem clinical data collected during ICU stay; correlation performed with post-mortem histopathology assessed within 6 hours of death.;Parenchymal/epithelial injury gradingTimepoint: Post-mortem histopathology assessed within 6 hours of death.;Describing the type of immune cells involved in terms of tissue invasion.Timepoint: Post-mortem histopathology assessed within 6 hours of death.

—

Countries

India

Contacts

Public ContactSiddhavivek Majage

All India Institute of Medical Sciences (AIIMS) New Delhi

rahulanand00@gmail.com9013082271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026