NCT06504316

OXiris for Abdominal SEptic Shock (OASES Study)

A Multicenter, Randomized Control Clinical Trial on the Effect of Adsorptive Filter oXiris on Hemodynamics of Abdominal Septic Shock Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study innovatively utilizes multi-modal hemodynamic monitoring (Norepinephrine equivalence, NEE+Pulse indicator Continuous Cariac output, PiCCO) to investigate the optimal timing of initiation of oXiris in abdominal infection-associated septic shock patients and to investigate prognosis on sepsis phenotypes undergoing oXiris therapy.

Detailed description

Sepsis is a life-threatening organ dysfunction syndrome caused by dysregulated host responses to infection, which is one of the leading causes of death for critically ill patients and also a challenge for clinicians. Abdominal infection is a common cause of septic shock, and is often transferred to intensive care unit (ICU) from emergency surgery, including appendectomy, cholecystectomy, intestinal repair or resection, incision and drainage of abscesses, and local debridement. The oXiris (Baxter) hemofiltration membrane is the only one on the market with the ability to adsorb both cytokines and endotoxin. This, together with the renal replacement function and its antithrombogenic properties, makes it unique in that it brings together four important functions in a single device. Endotoxin adsorption occurs thanks to a significant number of positively charged free amino groups in Polyethylene imine (PEI), which bind to the negatively charged endotoxin. This capacity is much more important, as oXiris has significantly more PEI compared to previous membranes. Therefore, from the perspective of structural principle, oXiris is currently an ideal adsorptive blood purification filter, which can not only perform conventional renal replacement therapy, but also perform adsorptive therapy to provide extra-renal support for sepsis. Therefore, in terms of the structural properties of the membrane, oXiris is currently an ideal adsorptive blood purification filter for both conventional renal replacement therapy for renal dysfunction treatment and extra-renal support for sepsis with endotoxin adsorption therapy. The investigaters hypothesis the adsorptive filter oXiris using for continuous renal replacement therapy (CRRT) can improve hemodynamic instability in abdominal septic shock patients, which rely on multimodal hemodynamics monitoring by PiCCO and ultrasound for early goal directed therapy.

Conditions

• Septic Shock
• Abdominal Sepsis
• Multi Organ Failure
• Blood Purification
• AKI - Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	CRRT filter	The subjects will be accepted CRRT using a filter for 72 hours. The subjects will be continued to CRRT or not after 72 hours (the first session of treatment) according to clinical situation by clinician decision. CRRT prescription: 1 Blood purification access: Central vein indwelling double lumen catheter (diameter 11F-13.5F) can be placed in femoral vein, internal jugular vein and subclavian vein; 2.Anti-coagulation prescription: Anticoagulant is used according clinical situation by clinician decision (such as heparin, sodium citrate, and so on); 3. Modality of CRRT: CVVH: blood flow 150-200ml/min; replacement fluid flow 30-35ml/kg/h (100% post-dilution).

Timeline

• Start date: 2024-08-15
• Primary completion: 2027-03-31
• Completion: 2027-05-31
• First posted: 2024-07-16
• Last updated: 2024-07-16

Locations

1 site across 1 country: China