Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504316
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-23
Brief Title:
OXiris for Abdominal SEptic Shock OASES Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Control Clinical Trial on the Effect of Adsorptive Filter oXiris on Hemodynamics of Abdominal Septic Shock Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OASES
Brief Summary:
This study innovatively utilizes multi-modal hemodynamic monitoring Norepinephrine equivalence NEEPulse 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None