Actively Recruiting

Age: 6Years +
All Genders
NCT06109142

Clearance of Vasoactive Metabolites With Blood Purification

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-09-19

30

Participants Needed

3

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clearance of Vasoactive Metabolites With Blood Purification

Who Can Participate

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to intensive care with vasoplegic shock receiving noradrenaline support
  • Adults or children aged 6 years or older and weighing at least 30 kg
  • Indication for extrarenal purification due to acute or chronic kidney failure, fluid overload, refractory metabolic acidosis, or severe electrolyte disorder
  • Clinician has decided to use the oXiris hemofilter with blood purification
  • Adult patients must not oppose participation, or if unable, have approval from a trusted person
  • Parental authority holders must not oppose participation for minor patients
Not Eligible

You will not qualify if you...

  • No need for hemofiltration treatment
  • Use of citrate anticoagulation for hemofiltration circuit
  • Participation in category 1 or 2 interventional study protocols; category 3 allowed after physician evaluation
  • Patients under judicial protection, guardianship, or curatorship
  • Patients without social security affiliation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Garches hospital

Garches, France, 92380

Not Yet Recruiting

2

Bicetre hospital

Le Kremlin-Bicêtre, France, 94250

Actively Recruiting

3

Hôpital Paul Brousse

Villejuif, France, 94800

Not Yet Recruiting

Loading map...

Research Team

P

Pierre Tissieres

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here