OXiris for Abdominal SEptic Shock (OASES Study)

N/ANot Yet RecruitingNCT06504316

RenJi Hospital192 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

192

Conditions

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

Interventions

CRRT filterDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

Outcomes

Primary Outcomes

The dose of vasopressor agents

Decrease range of NEE after initiation of CRRT

Time frame: CRRT 0, 6, 12, 24, 48, 72 hours

Secondary Outcomes

The value of PiCCO parameters

Increase range of cardiac index (CI) and systemic vascular resistance index (SVRI) after initiation of CRRT

Time frame: 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

Time frame: 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

Time frame: CRRT 0, 24, 48, 72 hours

The time of hospital stay

Length of hospital and ICU stay

Time frame: From date of randomization until the date of end of followup

The number of subjects of survival and kidney recovery

Survival and kidney recovery

Time frame: Day 28, 60, 90

Central Contacts

mingli zhu, MD

CONTACT

86-13701903155 millionzhu525@126.com

Data from ClinicalTrials.gov

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