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Recruiting NCT06853340

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

No phase Interventional Septic Shock Calcium Sensing Receptor Calcium Phosphate Disorders Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: blood sampling.
Who it may be relevant to
Registry conditions: Septic Shock, Calcium Sensing Receptor, Calcium Phosphate Disorders, Inflammation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Biological blood 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.

Primary outcome measures

  • Monocyte CaSR expression in healthy patient [Time frame: 1 day]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CHRU Amiens — Amiens

Identifiers

NCT: NCT06853340 · PI2023_843_0034

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗