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NCT Number: NCT06853340

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

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.

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Key information

Conditions

Septic Shock Calcium Phosphate Disorders Calcium Sensing Receptor Infections Inflammation Monocyte Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Aurélien MARY

SUB_INVESTIGATOR

Hervé Dupont, Pr

SUB_INVESTIGATOR

Julien Maizel

SUB_INVESTIGATOR

Quintana SOULIER

CONTACT

[email protected]

33+322057870

Romuald Mentaverri

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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,
  • patients with febrile neutropenia,
  • patients with acquired or constitutional immune system,
  • pregnant or breastfeeding patient,
  • patients under curators, guardianship or safeguard of justice.

Treatment and study plan

Blood sampling

Biological

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.

Primary outcomes

  1. Monocyte CaSR expression in healthy patient

    Time frame: 1 day

    Monocyte CaSR expression in healthy patient

Secondary outcomes

  1. Monocyte CasR expression in patient with septic shock

    Time frame: day 0

    Monocyte CasR expression in patient with septic shock

  2. Monocyte CasR expression in patient with septic shock

    Time frame: day 2

    Monocyte CasR expression in patient with septic shock

  3. Monocyte CasR expression in patient with septic shock

    Time frame: day 7

    Monocyte CasR expression in patient with septic shock

Study contacts

Contact information is provided by the study sponsor or research team.

Quintana SOULIER

CONTACT

[email protected]

33+322057870

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: CASRCHOC

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Feb 28, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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