Clearance of Vasoactive Metabolites With Blood Purification
ConditionCritically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
The target population for pediatric resuscitation concerns: * Patients in septic shock requiring extra-renal purification, i.e. 10-20 patients/year * Perioperative liver transplant patients, 20% of whom require extra-renal purification for multi-visceral failure associated with shock vasoplegic (5-10 patients/year) For adult resuscitations: * Patients in septic shock requiring extra-renal purification, i.e. 10-20% of these patients (30 patients per center per year for 2 centers) * Perioperative patients of major abdominal surgery with multi-organ renal failure requiring extra-renal purification (20 patients per year for a center).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
50% reduction in vasoinotropic score within 24 hours of initiation on oXiris.
Vaso-inotropic score calculated at baseline and H24. (Minimum 0 = better outcome)
Time frame
Baseline - 24 hoursSecondary outcomes
1
Evolution of the vaso-inotropic score within 72 hours of management
Vaso-inotropic score calculated at baseline - 3 hours - 6 hours - 12 hours - 24 hours - 48 hours - 72 hours (Minimum 0 = better outcome)
Time frame
Baseline - 3 hours - 6 hours - 12 hours - 24 hours - 48 hours - 72 hours2
Quantitative determination of angiotensins (Ang I, II, III, IV, 1-5, 1-7, 1-9, 2-7, 2-10 and 3-7) and regulatory enzymes (renin, angiotensin-converting enzyme, angiotensin-converting enzyme 2 and neprilysin).
Dosage of angiotensins (Ang I, II, III, IV, 1-5, 1-7, 1-9, 2-7, 2-10 and 3-7) and regulatory enzymes (renin, angiotensin-converting enzyme, angiotensin-converting enzyme 2 and neprilysin) by LC/MS
Time frame
Baseline - 24 hours - 72 hours3
Clearance of endothelial permeability markers (soluble E-selectin, thromboxane A2, endothelium-derived relaxing factor, bradykinin).
Dosage of Clearance of endothelial permeability markers (soluble E-selectin, thromboxane A2, endothelium-derived relaxing factor, bradykinin) by RT-PCR
Time frame
Baseline - 24 hours - 72 hours4
Markers of sepsis-induced immunosuppression expressed by HLA-DR monocytes in flow cytometry and selected cytokines (IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha).
Identification of Markers of sepsis-induced immunosuppression expressed by HLA-DR monocytes in flow cytometry and selected cytokines (IL-1 beta, IL-6, IL-8, IL-10, TNF-alpha) by flow cytometry
Time frame
Baseline - 24 hours - 72 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov