Blood purification for critically ill patients with vasoplegic shock
Pilot Study on the Effect of Oxiris Haemofiltration Membrane on Haemodynamic Stabilisation and Clearance of Vasoactive Metabolites
This study is testing if a special blood purification treatment can help critically ill patients with vasoplegic shock feel better and improve their blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 3 sites (Garches and 2 other locations) |
| Trial ID | NCT06109142 on ClinicalTrials.gov |
What this trial studies
This observational pilot study investigates the effects of extracorporeal blood purification using the oXiris hemofiltration membrane in critically ill patients experiencing vasoplegic shock. The study aims to measure both clinical and biological outcomes by collecting blood samples at baseline, 24 hours, and 72 hours after treatment initiation. The focus is on analyzing vasoactive metabolites and their impact on hemodynamics, particularly in patients requiring hemodynamic support. The methodology includes the use of specialized dialysis solutions and anticoagulation strategies tailored to individual patient needs.
Who should consider this trial
Good fit: Ideal candidates include adults and children aged 6 years and older with vasoplegic shock requiring hemodynamic support.
Not a fit: Patients who do not require hemofiltration or are under citrate anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hemodynamic stability and reduce the need for vasopressor medications in critically ill patients.
How similar studies have performed: Previous studies have shown promising results with similar blood purification techniques in critically ill patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 this trial is running
Garches and 2 other locations
- Garches hospital — Garches, France (Not_yet_recruiting)
- Bicetre hospital — Le Kremlin-Bicêtre, France (Recruiting)
- Hôpital Paul Brousse — Villejuif, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Pierre Tissieres — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Pierre Tissieres
- Email: pierre.tissieres@aphp.fr
- Phone: 0145213205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.