An interventional study of CRRT filter in Septic Shock, Abdominal Sepsis and Multi Organ Failure, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-16.
Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 192 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →RenJi Hospital is the lead sponsor of 550 studies on the registry; 247 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects will be accepted oXiris filter at the first treatment session for 72 hours.
Device: CRRT filter
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).
The dose of vasopressor agents
Decrease range of NEE after initiation of CRRT
Time frame: CRRT 0, 6, 12, 24, 48, 72 hours
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
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
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)
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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