OXiris for Abdominal SEptic Shock (OASES Study)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: oXirisExperimental treatment 1 intervention
Group B: ST 150Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

The time of hospital stay

Length of hospital and ICU stay

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

Other outcomes

1

The nmber of subjects of survival in phenotypes of septic shock

The survival of various phenotypes of septic shock

Time frame
Day 28, 60, 90
2

Filter lifespan

Duration of oXiris filter using and timing of changing filter

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

Sponsors and contacts

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