OXiris for Abdominal SEptic Shock (OASES Study) (OASES)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock; Blood Purification; Multi Organ Failure; Abdominal Sepsis; AKI - Acute Kidney Injury
• Intervention / Treatment: Device: CRRT filter

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.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mingli zhu, MD; Phone Number: 86-13701903155; Email: millionzhu525@126.com

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    • Contact: Mingli Zhu; Phone Number: 86-13701903155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years;
2. Weight ≥30 kg;
3. Intra-abdominal infection (blood or abdominal drainage fluid culture positive for Gram-negative bacteria or suspected to be caused by a Gram-negative agent);
4. Diagnostic septic shock (Sepsis 3.0): Sepsis was defined as "life-threatening organ dysfunction caused by a dysregulated host response to infection" with organ dysfunction defined as an increase in qSOFA ⩾2 points. Septic shock was defined as sepsis requiring vasoactive therapy to maintain mean arterial pressure (MAP) ⩾ 65 mmHg and lactate elevation to >2 mmol/L despite adequate volume resuscitation;
5. The dose of norepinephrine⩾0.4ug/kg/min;
6. PCT⩾50ug/L, and/or IL-6⩾1000pg/ml;
7. AKI stage II/III (Kidney Disease Improving Global Outcomes, KDIGO grade);
8. Duration of septic shock ≤48 hours.

Exclusion Criteria:

1. Patients with highly contagious infectious diseases, such as tuberculosis;
2. Pregnant and lying-in woman or lactation period;
3. Infection of other sites (no abdominal infection like pneumonia, central nervous system infection and so on);
4. CRRT cannot be performed for various reasons;
5. Death is expected within 48 hours of admission to the ICU;
6. Previous renal replacement therapy;
7. Patients that underwent cardio-pulmonary resuscitation (CPR);
8. Patients who will not sign the informed consent form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oXiris; The subjects will be accepted oXiris filter at the first treatment session for 72 hours.	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).
Active Comparator: ST 150; The subjects will be accepted ST 150 filter at the first treatment session for 72 hours.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The dose of vasopressor agents	Decrease range of NEE after initiation of CRRT	CRRT 0, 6, 12, 24, 48, 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The value of PiCCO parameters	Increase range of cardiac index (CI) and systemic vascular resistance index (SVRI) after initiation of CRRT	CRRT 0, 6, 12, 24, 36, 48, 72 hours
The level of inflammatory markers	Decrease range of serum procalcitonin (PCT), interleukin-6 (IL-6) level after initiation of CRRT	CRRT 0, 12, 24, 48, 72 hours
The severity of illness score Severity of illness score	Decrease range of Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) score during the first 72 hours	CRRT 0, 24, 48, 72 hours
The time of hospital stay	Length of hospital and ICU stay	From date of randomization until the date of end of followup
The number of subjects of survival and kidney recovery	Survival and kidney recovery	Day 28, 60, 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The nmber of subjects of survival in phenotypes of septic shock	The survival of various phenotypes of septic shock	Day 28, 60, 90
Filter lifespan	Duration of oXiris filter using and timing of changing filter	From time of filter initiation using until the time of filter changed or CRRT stop (if filter no changed)

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Sepsis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Shock, Septic; Intraabdominal Infections; Shock; Acute Kidney Injury; Multiple Organ Failure
• Other Study ID Numbers: LY2024-082-B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No