SepsisNCT07401329
Early and Late Neutrophil CD64 and Monocyte HLA-DR as Biomarkers for Septic Shock
An observational study of Sepsis and Septic Shock, run by Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2019to 31 Dec 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients aged over 18 years with a diagnosis of septic shock
Inclusion Criteria: Patients were eligible if they met all of the following:
- 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.
Exclusion Criteria: Patients were excluded if they met any of the following:
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Pandit Bhagwat Dayal Sharma Postgraduate Institute of Medical Sciences
Rohtak, Haryana, 124001
About this study
Study Summary: Neutrophil CD64 \& Monocyte HLA-DR in Septic Shock
What is studied?
Read more
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.
Read the detailed description
Detailed Protocol of the Study
- Title Early and late neutrophil CD64 and monocyte HLA-DR as biomarkers for septic shock.
- Study Design
- Type: Prospective, single-center, observational cohort study.
- Setting: Medical ICU of a tertiary care university teaching hospital in northern India.
- Duration: January 2019 - December 2019.
- Ethics Approval: Biomedical Research and Ethics Committee (BREC/18/194).
- Guidelines: Conducted in adherence with STROBE reporting standards.
- Objectives
- Primary Objective: To evaluate neutrophil CD64 (nCD64), monocyte HLA-DR (mHLA-DR), and the Sepsis Index as prognostic markers in septic shock.
- Secondary Objectives:
- Compare biomarker levels between survivors and non-survivors.
- Assess predictive accuracy of these markers for 28-day mortality using ROC analysis.
- Study Population
- Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of septic shock according to prevailing Sepsis-3 criteria.
- Written informed consent from patient or next of kin.
- Exclusion Criteria:
- Pregnant females.
- Active malignancy.
- Severe chronic liver disease.
- Chronic kidney disease requiring maintenance hemodialysis.
- Immunocompromised patients or those on immunomodulatory therapy prior to sepsis onset.
- Non-bacterial sepsis (viral, fungal, tubercular).
- Enrollment \& Sample Size
- Screened: 80 patients.
- Excluded: 24 (per exclusion criteria).
- Final cohort: 56 patients (37 survivors, 19 non-survivors).
- Controls: 20 healthy volunteers for baseline biomarker values.
- Data Collection
- Demographics: Age, sex, residence, BMI, smoking status.
- Clinical variables: Primary diagnosis, comorbidities, severity scores (qSOFA, SIRS, APACHE II), vital signs, organ dysfunction parameters (PaO₂/FiO₂, inotropic support, renal replacement therapy, GCS).
- Laboratory parameters: CBC, renal/liver function tests, ABG, primary diagnosis details.
- Outcome measures: ICU stay, ventilator days, 28-day mortality.
- Biomarker Assessment
- Markers:
- Neutrophil CD64 (nCD64).
- Monocyte HLA-DR (mHLA-DR).
- Sepsis Index = nCD64 ÷ mHLA-DR.
- Method: Flow cytometry (8-color FACS Canto II, BD Biosciences).
- Units: Mean Fluorescence Intensity (MFI).
- Time points:
- Day 1 (admission).
- Day 8 (follow-up).
- Statistical Analysis
- Software: SPSS v24 (IBM).
- Descriptive statistics: Mean ± SD for normal data; median (IQR) for skewed data.
- Comparisons:
- Independent t-test for normal distribution.
- Mann-Whitney U test for skewed data.
- Predictive analysis: ROC curves for nCD64, HLA-DR, and Sepsis Index.
- Significance threshold: p < 0.05 (two-sided).
- Outcomes
- Primary outcome: 28-day mortality.
- Secondary outcomes: ICU stay duration, ventilator days, organ dysfunction severity.
- Safety \& Compliance
- Biomedical waste: Managed per Biomedical Waste (Management and Handling) Rules.
- Patient safety: Standard ICU protocols followed; no intervention beyond routine care.
- Conditions
- Sepsis, Septic Shock
- Keywords
- HLADR, NCD64, sepsis, septic-shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Septic shock group | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from day of enrollment to day 8
To compare sepsis index on day 1 and day 8
Sepsis Index = nCD64 ÷ mHLA-DR.
Measured: From day of enrollment to day 8
Secondary outcomes (1)
Compare the concentration of nCD64, mHLA-DR MFI between survivors and non-survivors.
- Population: septic shock patients (survivors and non-survivors).
- Time points: Day 1 (early) and Day 8 (late).
- Markers: nCD64 (neutrophil CD64), mHLA-DR (monocyte HLA-DR)
- Outcome: 28-day mortality.
Measured: from enrollment to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start5 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aman Ahuja, Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak
- Investigators
- Dhruva Chaudhry, MBBS,MD,DM, Study director, Pandit BD Sharma Postgraduate Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401329
- Sponsor's protocol ID
- BREC/18/194
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Neutrophil CD64 and Monocyte HLA-DR as Biomarkers for Septic Shock
- ClinicalTrials.gov ID
- NCT07401329
- Acronym / sponsor ID
- BREC/18/194
- Conditions
- Sepsis, Septic Shock
- Keywords
- HLADR, NCD64, sepsis, septic-shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Pandit Bhagwat Dayal Sharma, PGIMS, RohtakUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Protocol of the Study
- Title Early and late neutrophil CD64 and monocyte HLA-DR as biomarkers for septic shock.
- Study Design
- Type: Prospective, single-center, observational cohort study.
- Setting: Medical ICU of a tertiary care university teaching hospital in northern India.
- Duration: January 2019 - December 2019.
- Ethics Approval: Biomedical Research and Ethics Committee (BREC/18/194).
- Guidelines: Conducted in adherence with STROBE reporting standards.
- Objectives
- Primary Objective: To evaluate neutrophil CD64 (nCD64), monocyte HLA-DR (mHLA-DR), and the Sepsis Index as prognostic markers in septic shock.
- Secondary Objectives:
- Compare biomarker levels between survivors and non-survivors.
- Assess predictive accuracy of these markers for 28-day mortality using ROC analysis.
- Study Population
- Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of septic shock according to prevailing Sepsis-3 criteria.
- Written informed consent from patient or next of kin.
- Exclusion Criteria:
- Pregnant females.
- Active malignancy.
- Severe chronic liver disease.
- Chronic kidney disease requiring maintenance hemodialysis.
- Immunocompromised patients or those on immunomodulatory therapy prior to sepsis onset.
- Non-bacterial sepsis (viral, fungal, tubercular).
- Enrollment \& Sample Size
- Screened: 80 patients.
- Excluded: 24 (per exclusion criteria).
- Final cohort: 56 patients (37 survivors, 19 non-survivors).
- Controls: 20 healthy volunteers for baseline biomarker values.
- Data Collection
- Demographics: Age, sex, residence, BMI, smoking status.
- Clinical variables: Primary diagnosis, comorbidities, severity scores (qSOFA, SIRS, APACHE II), vital signs, organ dysfunction parameters (PaO₂/FiO₂, inotropic support, renal replacement therapy, GCS).
- Laboratory parameters: CBC, renal/liver function tests, ABG, primary diagnosis details.
- Outcome measures: ICU stay, ventilator days, 28-day mortality.
- Biomarker Assessment
- Markers:
- Neutrophil CD64 (nCD64).
- Monocyte HLA-DR (mHLA-DR).
- Sepsis Index = nCD64 ÷ mHLA-DR.
- Method: Flow cytometry (8-color FACS Canto II, BD Biosciences).
- Units: Mean Fluorescence Intensity (MFI).
- Time points:
- Day 1 (admission).
- Day 8 (follow-up).
- Statistical Analysis
- Software: SPSS v24 (IBM).
- Descriptive statistics: Mean ± SD for normal data; median (IQR) for skewed data.
- Comparisons:
- Independent t-test for normal distribution.
- Mann-Whitney U test for skewed data.
- Predictive analysis: ROC curves for nCD64, HLA-DR, and Sepsis Index.
- Significance threshold: p < 0.05 (two-sided).
- Outcomes
- Primary outcome: 28-day mortality.
- Secondary outcomes: ICU stay duration, ventilator days, organ dysfunction severity.
- Safety \& Compliance
- Biomedical waste: Managed per Biomedical Waste (Management and Handling) Rules.
- Patient safety: Standard ICU protocols followed; no intervention beyond routine care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic shock group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged over 18 years with a diagnosis of septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the concentration of nCD64, mHLA-DR in mean fluorescence intensity (MFI) on day 1 and 8
Time frame: from day of enrollment to day 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.
To compare sepsis index on day 1 and day 8
Time frame: From day of enrollment to day 8
Sepsis Index = nCD64 ÷ mHLA-DR.
1 secondary outcome
Compare the concentration of nCD64, mHLA-DR MFI between survivors and non-survivors.
Time frame: from enrollment to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhruva Chaudhry, MBBS,MD,DM study director
Pandit BD Sharma Postgraduate Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the concentration of nCD64, mHLA-DR in mean fluorescence intensity (MFI) on day 1 and 8 (time frame: from day of enrollment to day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.