Septic ShockOASESNCT06504316
OXiris for Abdominal SEptic Shock (OASES Study)
A study testing CRRT filter in people with Septic Shock and Abdominal Sepsis, run by RenJi Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Abdominal Sepsis, Multi Organ Failure
- What is being tested?
- CRRT filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, 200127
Mingli Zhu, 86-13701903155
About this study
Official title: A Multicenter, Randomized Control Clinical Trial on the Effect of Adsorptive Filter oXiris on Hemodynamics of Abdominal Septic Shock Patients
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.
Read the detailed description
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.
- Conditions
- Septic Shock, Abdominal Sepsis, Multi Organ Failure, Blood Purification, AKI - Acute Kidney Injury
- Being tested
- CRRT filter
- Medical subject headings
- Shock, Septic, Intraabdominal Infections, Multiple Organ Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| oXiris | Experimental | The subjects will be accepted oXiris filter at the first treatment session for 72 hours. Receives: Device: CRRT filter |
| ST 150 | Active comparator | The subjects will be accepted ST 150 filter at the first treatment session for 72 hours. Receives: Device: CRRT filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose of vasopressor agents
Decrease range of NEE after initiation of CRRT
Measured: CRRT 0, 6, 12, 24, 48, 72 hours
Secondary outcomes (5)
The value of PiCCO parameters
Increase range of cardiac index (CI) and systemic vascular resistance index (SVRI) after initiation of CRRT
Measured: 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
Measured: 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
Measured: CRRT 0, 24, 48, 72 hours
The time of hospital stay
Length of hospital and ICU stay
Measured: From date of randomization until the date of end of followup
The number of subjects of survival and kidney recovery
Survival and kidney recovery
Measured: Day 28, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison two groups: intervention group (oXiris filter) and control group (ST 150 filter)
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504316
- Sponsor's protocol ID
- LY2024-082-B
- Acronym
- OASES
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen J, Zhang Z, Gao J, Liu Y, Zhu B, Gao Y, Zhuang Y, Zhu M. A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study). BMJ Open. 2025 Jul 8;15(7):e094792. doi: 10.1136/bmjopen-2024-094792.
PubMed 40633959
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Control Clinical Trial on the Effect of Adsorptive Filter oXiris on Hemodynamics of Abdominal Septic Shock Patients
- ClinicalTrials.gov ID
- NCT06504316
- Acronym / sponsor ID
- OASES / LY2024-082-B
- Conditions
- Septic Shock, Abdominal Sepsis, Multi Organ Failure, Blood Purification, AKI - Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison two groups: intervention group (oXiris filter) and control group (ST 150 filter)
| Arm | Type | Receives |
|---|---|---|
| oXiris | Experimental | Device: CRRT filterThe subjects will be accepted oXiris filter at the first treatment session for 72 hours. |
| ST 150 | Active comparator | Device: CRRT filterThe subjects will be accepted ST 150 filter at the first treatment session for 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRRT filterThe 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). | Device | ST 150, oXiris |
Primary outcome
The dose of vasopressor agents
Time frame: CRRT 0, 6, 12, 24, 48, 72 hours
Decrease range of NEE after initiation of CRRT
5 secondary outcomes
The value of PiCCO parameters
Time frame: CRRT 0, 6, 12, 24, 36, 48, 72 hours
The level of inflammatory markers
Time frame: CRRT 0, 12, 24, 48, 72 hours
The severity of illness score Severity of illness score
Time frame: CRRT 0, 24, 48, 72 hours
The time of hospital stay
Time frame: From date of randomization until the date of end of followup
The number of subjects of survival and kidney recovery
Time frame: Day 28, 60, 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 40633959Chen J, Zhang Z, Gao J, Liu Y, Zhu B, Gao Y, Zhuang Y, Zhu M. A multicentre, randomised controlled clinical trial evaluating the effect of the adsorptive filter oXiris on haemodynamics in abdominal septic shock patients requiring continuous renal replacement therapy (Oxiris for Abdominal SEptic Shock study). BMJ Open. 2025 Jul 8;15(7):e094792. doi: 10.1136/bmjopen-2024-094792.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRRT filter in people with Septic Shock and Abdominal Sepsis, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mingli zhu, MD (86-13701903155, millionzhu525@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose of vasopressor agents (time frame: CRRT 0, 6, 12, 24, 48, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.