An interventional study of Arterial blood sampling and Ultrafiltrate sampling in Septic Shock and Peritonitis, sponsored by Hospices Civils de Lyon. Completed at 8 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.
The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 39 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients included in this arm will have renal replacement therapy by performing Continuous Veno-Venous Hemofiltration (CVVH) using oXiris™ membrane. They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH.
Biological: Arterial blood sampling · Biological: Ultrafiltrate sampling · Device: CVVH using oXiris™ filter
Patients included in this arm will have renal replacement therapy by performing CVVH using a standard polysulfone filter (PrismafleX HF1400). They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH.
Biological: Arterial blood sampling · Biological: Ultrafiltrate sampling · Device: CVVH using PrismafleX HF1400 filter
All patients will have arterial blood sampling to assess pre-filter and post-filter plasma endotoxin mass and activity and plasma cytokine levels
All patients will have ultrafiltrate sampling to assess cytokine levels
Patients included in the experimental arm will have renal replacement therapy by performing CVVH using oXiris™ filter
Patients included in the experimental arm will have renal replacement therapy by performing CVVH using PrismafleX HF1400 filter
Interleukin 6 (IL-6) plasmatic concentration
Time frame: 24 hours after the initiation of CVVH
Endotoxin plasmatic mass concentration
Time frame: 24 hours after the initiation of CVVH
Pre-filter plasma endotoxin mass
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma endotoxin activity
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma endotoxin mass
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma endotoxin activity
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma cytokine level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma cytokine level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Ultrafiltrate cytokine level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma lipids level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma lipids level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma Procalcitonin level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma Procalcitonin level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma Phospholipid Transfer Protein level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma Phospholipid Transfer Protein level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma Cholesteryl Ester Transfer Protein level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma Cholesteryl Ester Transfer Protein level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Pre-filter plasma lipopolysaccharide (LPS) Binding Protein level
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Post-filter plasma LPS-Binding Protein level
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Norepinephrine requirements
Time frame: 4, 12 and 24 hours after the initiation of CVVH
Fluids infused
Time frame: 4, 12 and 24 hours after the initiation of CVVH
Patient survival
Time frame: At day 7
Patient survival
Time frame: At day 30
Patient survival
Time frame: At day 90
Comparison of the results obtained on the above-mentioned parameters, according to the type of bacteria identified from standard care microbiological exams.
Time frame: At day 7
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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