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NCT Number: NCT06504316

OXiris for Abdominal SEptic Shock (OASES Study)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • Weight ≥30 kg;
  • Intra-abdominal infection (blood or abdominal drainage fluid culture positive for Gram-negative bacteria or suspected to be caused by a Gram-negative agent);
  • 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;
  • The dose of norepinephrine⩾0.4ug/kg/min;
  • PCT⩾50ug/L, and/or IL-6⩾1000pg/ml;
  • AKI stage II/III (Kidney Disease Improving Global Outcomes, KDIGO grade);
  • Duration of septic shock ≤48 hours.

Exclusion criteria

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

Treatment and study plan

CRRT filter

Device

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).

Primary outcomes

  1. The dose of vasopressor agents

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

    Decrease range of NEE after initiation of CRRT

Secondary outcomes

  1. The value of PiCCO parameters

    Time frame: CRRT 0, 6, 12, 24, 36, 48, 72 hours

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

  2. The level of inflammatory markers

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

    Decrease range of serum procalcitonin (PCT), interleukin-6 (IL-6) level after initiation of CRRT

  3. The severity of illness score Severity of illness score

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

    Decrease range of Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) score during the first 72 hours

  4. The time of hospital stay

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

    Length of hospital and ICU stay

  5. The number of subjects of survival and kidney recovery

    Time frame: Day 28, 60, 90

    Survival and kidney recovery

Other outcomes

  1. The nmber of subjects of survival in phenotypes of septic shock

    Time frame: Day 28, 60, 90

    The survival of various phenotypes of septic shock

  2. Filter lifespan

    Time frame: From time of filter initiation using until the time of filter changed or CRRT stop (if filter no changed)

    Duration of oXiris filter using and timing of changing filter

Study contacts

Contact information is provided by the study sponsor or research team.

mingli zhu, MD

CONTACT

[email protected]

86-13701903155

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Acronym: OASES

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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