Clearance of Vasoactive Metabolites With Blood Purification

Recruiting now

Conditions studied: Critically Ill Patients

In brief

Extracorporeal blood purification is a supportive therapy in the management of patients with sepsis or vasoplegic shock. The pathophysiology of sepsis is based on an inappropriate host response to infection. Certain medical devices with higher adsorption capacity make it possible to limit this inappropriate response and could thus improve the hemodynamics of patients in septic or vasoplegic shock. The preliminary experience of the investigators from clinical data of vasopressor withdrawal in pediatric patients treated with oXiris shows a 50% reduction in the vasopressor score, Vaso Inotropic Score (VIS), for 40% of patients within 24 hours following the start of treatment. Similar results were found in adult patients treated for severe COVID-19 or vasoplegic shock by the other centers participating in the study. Cytokine purification is an important physiological effect of purification membranes. However, this may not fully explain the rapid hemodynamic improvement of patients treated with an oXiris membrane. The role of angiotensin metabolites (Ang 1-5, 1-7, 1-9) in the systemic vascular tone of patients has been recently discussed. The administration of angiotensin 2 in vasoplegic shock in adults helps correct hypotension. In the group of patients with increased renin, this treatment was associated with a reduction in mortality. Indeed, increased renin associated with dysfunction of Angiotensin Converting Enzyme (ACE) leads to an accumulation of Angiotensin 1 which degrades to Ang 1-7. The hypothesis f the investigators is that the concentration of Ang 1 and Ang 1-7 is elevated in cases of vasoplegic shock and that the clearance of these vasodilator peptides by blood purification is associated with clinical improvement.

Key facts

Study ID

NCT06109142

Run by

Assistance Publique - Hôpitaux de Paris

People needed

30

Starts

2024-07-11

Expected to finish

2026-06-11

Last updated by the study team

2024-09-19

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients admitted to intensive care with vasoplegic shock (hemodynamic support by noradrenaline).
• Adult or child ≥ 6 years and 30kg
• Indication for extrarenal purification for acute, chronic renal failure, oliguric hydrosodic overload, refractory metabolic acidosis or severe hydroelectrolyte disorder
• Clinician's decision to use an oXiris hemofilter with blood purification capability
• For adult patients: no opposition from the patient (or person of trust or close friend if the patient is unable to be informed)
• For minor patients: no opposition of the holders of parental authority

You may not qualify if…

• No need for hemofiltration.
• Citrate anticoagulation of the hemofiltration circuit
• Inclusion in a category 1 or 2 interventional study protocol. Patients included in category 3 interventional research will be able to participate in the study after assessment by the physician.
• Patient under judicial protection and adults under guardianship or curatorship.
• Patient with no social security affiliation

Where it is running

• Bicetre hospital — Le Kremlin-Bicêtre, France (enrolling)
• Garches hospital — Garches, France
• Hôpital Paul Brousse — Villejuif, France

Full record on ClinicalTrials.gov

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