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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
CRRT filter
DeviceThe 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
Trial outcomes
Primary outcomes
The dose of vasopressor agents
Decrease range of NEE after initiation of CRRT
Secondary outcomes
The value of PiCCO parameters
Increase range of cardiac index (CI) and systemic vascular resistance index (SVRI) after initiation of CRRT
The level of inflammatory markers
Decrease range of serum procalcitonin (PCT), interleukin-6 (IL-6) level after initiation of CRRT
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
The time of hospital stay
Length of hospital and ICU stay
Other outcomes
The nmber of subjects of survival in phenotypes of septic shock
The survival of various phenotypes of septic shock
Filter lifespan
Duration of oXiris filter using and timing of changing filter
Sponsors and contacts
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