Early and Late Neutrophil CD64 and Monocyte HLA-DR as Biomarkers for Septic Shock

NCT07401329 | Completed

• 1 other identifier: BREC/18/194
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Study Summary: Neutrophil CD64 \& Monocyte HLA-DR in Septic Shock What is studied? Doctors looked at two blood markers:

• Neutrophil CD64 (nCD64): rises quickly when the body fights infection.
• Monocyte HLA-DR (mHLA-DR): falls when the immune system becomes weak or "paralyzed." They also calculated a Sepsis Index (ratio of nCD64 to HLA-DR) to see how these markers change in patients with septic shock. Why is this important? Septic shock is a severe form of sepsis that can cause organ failure and death. Early detection and knowing which patients are at higher risk can guide treatment and improve survival. How was it done?
• Blood samples were taken on Day 1 (early) and Day 8 (late).
• Results will be compared between survivors and non-survivors.
• 20 healthy people provided baseline values for comparison. What does this mean? - Monitoring these markers over time (not just once) may helps doctors understand whether a patient's immune system is recovering or worsening. Take-home message For patients and families: \- Septic shock is serious, but doctors now have better tools to track how the body is responding.

Conditions

Sepsis; Septic Shock

Keywords

HLADR; NCD64; sepsis; septic-shock

Outcome Measures

Primary Outcomes (2)

• Measure the concentration of nCD64, mHLA-DR in mean fluorescence intensity (MFI) on day 1 and 8

  * Sample Collection: Peripheral blood samples taken from patients with septic shock. * Technique: Flow cytometry using an 8-color FACS Canto II (BD Biosciences). * Units: Results expressed as Mean Fluorescence Intensity (MFI). * Calculation: * nCD64 measured directly on neutrophils. * mHLA-DR measured directly on monocytes.

  from day of enrollment to day 8

• To compare sepsis index on day 1 and day 8

  Sepsis Index = nCD64 ÷ mHLA-DR.

  From day of enrollment to day 8

Secondary Outcomes (1)

• Compare the concentration of nCD64, mHLA-DR MFI between survivors and non-survivors.

  from enrollment to day 28

Study Arms (2)

Septic shock group

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged over 18 years with a diagnosis of septic shock

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of septic shock according to prevailing Sepsis-3 criteria at the time of study.
• Admission to the medical ICU of the tertiary care teaching hospital.
• Written informed consent obtained from patient or next of kin.

You may not qualify if:

• Pregnant females.
• Active malignancy (any known cancer diagnosis).
• Severe chronic liver disease.
• Chronic kidney disease requiring maintenance hemodialysis.
• Immunocompromised state, including:
• HIV/AIDS.
• Long-term corticosteroid therapy.
• Other immunosuppressive conditions.
• Prior immunomodulatory treatment before onset of sepsis (e.g., biologics, GM-CSF, interferons).
• Non-bacterial sepsis, including:
• Viral sepsis.
• Fungal sepsis.
• Tubercular sepsis.

Sponsors & Collaborators

• Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak: lead

Study Sites (1)

Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Dhruva Chaudhry, MBBS,MD,DM

  Pandit BD Sharma Postgraduate Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of PCCM

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 10, 2026
• Study Start: January 5, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

IN (1)