Pilot Study on the Effect of Oxiris Haemofiltration Membrane on Haemodynamic Stabilisation and Clearance of Vasoactive Metabolites

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Garches hospital
NOT_YET_RECRUITING
Garches
Bicetre hospital
RECRUITING
Le Kremlin-bicêtre
Hôpital Paul Brousse
NOT_YET_RECRUITING
Villejuif
Contact Information
Primary
Pierre Tissieres
pierre.tissieres@aphp.fr
0145213205
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2026-06-11
Participants
Target number of participants: 30
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov