Arterial blood sampling
BiologicalAll patients will have arterial blood sampling to assess pre-filter and post-filter plasma endotoxin mass and activity and plasma cytokine levels
NCT Number: NCT03426943
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hopital Universitaire de Clermont Ferrand, Clermont-Ferrand, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 24 hours after the initiation of CVVH
Time frame: 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 1, 4, 12 and 24 hours after the initiation of CVVH
Time frame: 4, 12 and 24 hours after the initiation of CVVH
Time frame: 4, 12 and 24 hours after the initiation of CVVH
Time frame: At day 7
Time frame: At day 30
Time frame: At day 90
Time frame: At day 7
Hospices Civils de Lyon
Other
Acronym: ECRO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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