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

NCT06853340 | Recruiting DMC

• 1 other identifier: PI2023_843_0034
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Septic shock; Calcium Sensing Receptor; Calcium Phosphate disorders; Inflammation; Monocyte

Outcome Measures

Primary Outcomes (1)

• Monocyte CaSR expression in healthy patient

  Monocyte CaSR expression in healthy patient

  1 day

Secondary Outcomes (3)

• Monocyte CasR expression in patient with septic shock

  day 0

• Monocyte CasR expression in patient with septic shock

  day 2

• Monocyte CasR expression in patient with septic shock

  day 7

Study Arms (2)

healthy volunteers

ACTIVE COMPARATOR

patients in septic shock

EXPERIMENTAL

Biological: blood sampling

Interventions

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.

patients in septic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHRU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Quintana SOULIER

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: February 24, 2025
• Primary Completion: April 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)