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Recruiting NCT06853340

NCT06853340 Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock

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Clinical Trial Summary
NCT ID NCT06853340
Status Recruiting
Phase
Sponsor Centre Hospitalier Universitaire, Amiens
Condition Septic Shock
Study Type INTERVENTIONAL
Enrollment 66 participants
Start Date 2025-02-24
Primary Completion 2025-04-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
blood sampling

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 66 participants in total. It began in 2025-02-24 with a primary completion date of 2025-04-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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.

Contact & Investigator

Central Contact

Quintana SOULIER

✉ Soulier-Zaninka.Quintana@chu-amiens.fr

📞 33+322057870

Frequently Asked Questions

Who can join the NCT06853340 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06853340 currently recruiting?

Yes, NCT06853340 is actively recruiting participants. Contact the research team at Soulier-Zaninka.Quintana@chu-amiens.fr for enrollment information.

Where is the NCT06853340 trial being conducted?

This trial is being conducted at Amiens, France.

Who is sponsoring the NCT06853340 clinical trial?

NCT06853340 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 66 participants.

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