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RecruitingNCT06853340CASRCHOCUpdated Apr 25, 2025

Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock

An interventional study of blood sampling in Septic Shock, Calcium Sensing Receptor and Calcium Phosphate Disorders, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Septic Shock
  • Calcium Sensing Receptor
  • Calcium Phosphate Disorders
  • Inflammation
  • Monocyte

Keywords

  • Septic shock
  • Calcium Sensing Receptor
  • Calcium Phosphate disorders
  • Inflammation
  • Monocyte
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 66 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patients over the age of 18,
  • patients who have not participated in a study evaluating an 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.

Exclusion criteria

Exclusion Criteria:

  • Patients in hemorrhagic shock,
  • history of parathyroidectomy, patient with hypersecretion of PTHrp,
  • sarcoidosis,
  • genetic disturbance of CaSR including familial hypocalciuric hypercalcaemia,
  • current treatment (anticalcineurin, mTOR inhibitor, methotrexate, high-dose excluding hydrocortisone and fludrocortisone),
  • chronic myelomonocytic leukemia,
  • patients with febrile neutropenia,
  • patients with acquired or constitutional immune system,
  • pregnant or breastfeeding patient,
  • patients under curators, guardianship or safeguard of justice.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Active comparator
    healthy volunteers
  • Experimental
    patients in septic shock

    Biological: blood sampling

Interventions

  • Biologicalblood sampling

    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.

06

What researchers measure

Primary outcomes

  1. Monocyte CaSR expression in healthy patient

    Monocyte CaSR expression in healthy patient

    Time frame: 1 day

Secondary outcomes

  1. Monocyte CasR expression in patient with septic shock

    Monocyte CasR expression in patient with septic shock

    Time frame: day 0

  2. Monocyte CasR expression in patient with septic shock

    Monocyte CasR expression in patient with septic shock

    Time frame: day 2

  3. Monocyte CasR expression in patient with septic shock

    Monocyte CasR expression in patient with septic shock

    Time frame: day 7

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06853340
Responsible party
Sponsor
First posted
Feb 28, 2025
Start date
Feb 24, 2025
Primary completion
Apr 1, 2025
Completion
Feb 2027 (estimated)
Last update
Apr 25, 2025

Study contacts

Quintana SOULIER
Contact
Soulier-Zaninka.Quintana@chu-amiens.fr
33+322057870

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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