Septic ShockCASRCHOCNCT06853340
Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock
A study testing blood sampling in people with Septic Shock and Calcium Sensing Receptor, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In septic shock, bacterial LPS is able to activate the CaSR of cardiomyocytes inducing their apoptosis in vitro. CaSR activation in monocytes is responsible for activation of the NLRP3 inflammasome and macropinocytosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock, Calcium Sensing Receptor, Calcium Phosphate Disorders
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female patients over the age of 18,
- patients who have not participated in a study evaluating an investigational drug in the 30 days preceding the samples,
- intensive care patients in a state of septic shock within the first 24 hours of the introduction of pressor amines,
- French resident year-round,
- lactate > 2mmol/L,
- patients with social security coverage.
Who cannot join
- Patients in hemorrhagic shock,
- history of parathyroidectomy, patient with hypersecretion of PTHrp,
- sarcoidosis,
- genetic disturbance of CaSR including familial hypocalciuric hypercalcaemia,
- current immunosuppressant treatment (anticalcineurin, mTOR inhibitor, methotrexate, high-dose corticosteroids excluding hydrocortisone and fludrocortisone),
- chronic myelomonocytic leukemia,
Show all 10Show fewer
- patients with febrile neutropenia,
- patients with acquired or constitutional immune system,
- pregnant or breastfeeding patient,
- patients under curators, guardianship or safeguard of justice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Amiens
Amiens, 80480
Quintana SOULIER, 33+322057870, Soulier-Zaninka.Quintana@chu-amiens.fr
Aurélien MARY
About this study
In septic shock, bacterial LPS is able to activate the CaSR of cardiomyocytes inducing their apoptosis in vitro. CaSR activation in monocytes is responsible for activation of the NLRP3 inflammasome and macropinocytosis. In front of this immune axis, a variation in the monocyte expression of the CaSR is expected in the state of shock. This is already observed in other pathologies such as renal failure or in animal models of severe burns. If this is considered as an overall reflection of CaSR expression in the body, it would be consistent with the phosphocalcic disturbances associated with septic shock. The phosphocalcic balance is often modified, and not treated during the acute episode, with in particular hypocalcaemia which could be consecutive to a hyperactivation or overexpression of the CaSR. This study proposes to explore for the first time the expression of monocytic CaSR in patients in a state of shock, with possible therapeutic perspectives by the existence of calcimimetics and calcilytics. In this study, the investigators propose to explore the CasR and its implication in septic shock in a three - part protocol : measurement by flow cytometry of monocyte expression of CASR (primary objective) and CD33, CD14, CD163, CD16 and HLA-DR), survey of clinical and biological parameters in patients with septic shock and healthy volunteers and acquisition of calcium score in patients with septic shock.
- Conditions
- Septic Shock, Calcium Sensing Receptor, Calcium Phosphate Disorders, Inflammation, Monocyte
- Being tested
- blood sampling
- Keywords
- Septic shock, Calcium Sensing Receptor, Calcium Phosphate disorders, Inflammation, Monocyte
- Medical subject headings
- Shock, Septic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Patients with septic shock will have three differents times of blood sampling and of clinical and biological statements. Healthy volunteers will have a unique visit to collect clinical data and blood samples.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Active comparator | Not described |
| patients in septic shock | Experimental | Not described Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte CaSR expression in healthy patient
Monocyte CaSR expression in healthy patient
Measured: 1 day
Secondary outcomes (3)
Monocyte CasR expression in patient with septic shock
Monocyte CasR expression in patient with septic shock
Measured: day 0
Monocyte CasR expression in patient with septic shock
Monocyte CasR expression in patient with septic shock
Measured: day 2
Monocyte CasR expression in patient with septic shock
Monocyte CasR expression in patient with septic shock
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start24 Feb 2025
- Primary completion1 Apr 2025
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853340
- Sponsor's protocol ID
- PI2023_843_0034
- Acronym
- CASRCHOC
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock
- ClinicalTrials.gov ID
- NCT06853340
- Acronym / sponsor ID
- CASRCHOC / PI2023_843_0034
- Conditions
- Septic Shock, Calcium Sensing Receptor, Calcium Phosphate Disorders, Inflammation, Monocyte
- Keywords
- Septic shock, Calcium Sensing Receptor, Calcium Phosphate disorders, Inflammation, Monocyte
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
In septic shock, bacterial LPS is able to activate the CaSR of cardiomyocytes inducing their apoptosis in vitro. CaSR activation in monocytes is responsible for activation of the NLRP3 inflammasome and macropinocytosis. In front of this immune axis, a variation in the monocyte expression of the CaSR is expected in the state of shock. This is already observed in other pathologies such as renal failure or in animal models of severe burns. If this is considered as an overall reflection of CaSR expression in the body, it would be consistent with the phosphocalcic disturbances associated with septic shock. The phosphocalcic balance is often modified, and not treated during the acute episode, with in particular hypocalcaemia which could be consecutive to a hyperactivation or overexpression of the CaSR. This study proposes to explore for the first time the expression of monocytic CaSR in patients in a state of shock, with possible therapeutic perspectives by the existence of calcimimetics and calcilytics. In this study, the investigators propose to explore the CasR and its implication in septic shock in a three - part protocol : measurement by flow cytometry of monocyte expression of CASR (primary objective) and CD33, CD14, CD163, CD16 and HLA-DR), survey of clinical and biological parameters in patients with septic shock and healthy volunteers and acquisition of calcium score in patients with septic shock.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Active comparator | – |
| patients in septic shock | Experimental | Biological: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients over the age of 18,
- patients who have not participated in a study evaluating an investigational drug in the 30 days preceding the samples,
- intensive care patients in a state of septic shock within the first 24 hours of the introduction of pressor amines,
- French resident year-round,
- lactate > 2mmol/L,
Key exclusion criteria (10 listed)
- Patients in hemorrhagic shock,
- history of parathyroidectomy, patient with hypersecretion of PTHrp,
- sarcoidosis,
- genetic disturbance of CaSR including familial hypocalciuric hypercalcaemia,
- current immunosuppressant treatment (anticalcineurin, mTOR inhibitor, methotrexate, high-dose corticosteroids excluding hydrocortisone and fludrocortisone),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingPatients with septic shock will have three differents times of blood sampling and of clinical and biological statements. Healthy volunteers will have a unique visit to collect clinical data and blood samples. | Biological | patients in septic shock |
Primary outcome
Monocyte CaSR expression in healthy patient
Time frame: 1 day
Monocyte CaSR expression in healthy patient
3 secondary outcomes
Monocyte CasR expression in patient with septic shock
Time frame: day 0
Monocyte CasR expression in patient with septic shock
Time frame: day 2
Monocyte CasR expression in patient with septic shock
Time frame: day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Thymosin Alpha 1 and IgM Levels in Sepsis
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Septic Shock and Calcium Sensing Receptor, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 25 Apr 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quintana SOULIER (33+322057870, Soulier-Zaninka.Quintana@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocyte CaSR expression in healthy patient (time frame: 1 day). 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 25 Apr 2025.