Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06109142
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-02
Brief Title:
Clearance of Vasoactive Metabolites With Blood Purification
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pilot Study on the Effect of Oxiris Haemofiltration Membrane on Haemodynamic Stabilisation and Clearance of Vasoactive Metabolites
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITAL
Brief 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
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
Detailed Description:
This is a pilot study non-interventional research involving the human subjects category 3 aimed at measuring the clinical and biological the clinical and biological effects of using the oXiris hemofiltration hemofiltration membrane
As part of the treatment oXiris membrane hemofiltration with Prismaflex system Phoxylium or Hémosol B0 dialysis solution upper or lower dialysis catheter Anticoagulation with heparin citrate or none in case of severe haemostasis disorders Treatment volume of 35 mlkgh maximum
For research purposes collection of additional blood tubes 2 x 5mL heparinized tube added to the usual samples at the following times
Baseline before starting treatment under hemofiltration at 24h - 6h of treatment and at 72 hours - 12 hours
These samples will be analyzed by liquid chromatography - mass spectrometry mass spectrometry LC-MSMS by Attoquant diagnostics a laboratory specialized in analyses of the Renin-Angiotensin system The angiotensins assayed are Angiotensin I II III and IV as well as the intermediate peptides 1-5 1-7 1-9 2-10 2-7 and 3-7 and regulatory enzymes renin angiotensin converting enzyme angiotensin 2-converting enzyme and neprilysin
Angiotensin metabolites have a very short half-life Their depends on enzyme activity and degradation by circulating proteases Two techniques are used to determine circulating concentration rapid treatment with protease inhibitors or the equilibrium technique
For the equilibrium technique samples are incubated again to restore metabolite concentration prior to analysis The samples at 3 time points Baseline H24 and H72 are analyzed using the equilibrium The H24 sample will also be analyzed with a protease inhibitor pre-treatment
Patients will be monitored for 3 months 90-day mortality using data collected collected in the course of care
Data from medical records and biological analyses will be entered into an eCRF Data management will be carried out throughout the study to enable baseline freezing and statistical analysis as early as possible after the end of the last patients follow-up
As part of the treatment oXiris membrane hemofiltration with Prismaflex system Phoxylium or Hémosol B0 dialysis solution upper or lower dialysis catheter Anticoagulation with heparin citrate or none in case of severe haemostasis disorders Treatment volume of 35 mlkgh maximum
For research purposes collection of additional blood tubes 2 x 5mL heparinized tube added to the usual samples at the following times
Baseline before starting treatment under hemofiltration at 24h - 6h of treatment and at 72 hours - 12 hours
These samples will be analyzed by liquid chromatography - mass spectrometry mass spectrometry LC-MSMS by Attoquant diagnostics a laboratory specialized in analyses of the Renin-Angiotensin system The angiotensins assayed are Angiotensin I II III and IV as well as the intermediate peptides 1-5 1-7 1-9 2-10 2-7 and 3-7 and regulatory enzymes renin angiotensin converting enzyme angiotensin 2-converting enzyme and neprilysin
Angiotensin metabolites have a very short half-life Their depends on enzyme activity and degradation by circulating proteases Two techniques are used to determine circulating concentration rapid treatment with protease inhibitors or the equilibrium technique
For the equilibrium technique samples are incubated again to restore metabolite concentration prior to analysis The samples at 3 time points Baseline H24 and H72 are analyzed using the equilibrium The H24 sample will also be analyzed with a protease inhibitor pre-treatment
Patients will be monitored for 3 months 90-day mortality using data collected collected in the course of care
Data from medical records and biological analyses will be entered into an eCRF Data management will be carried out throughout the study to enable baseline freezing and statistical analysis as early as possible after the end of the last patients follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01439-34 | REGISTRY | IDRCB | None |