Septic ShockNCT07807410
Early Endotoxin Burden Reduction With oXiris in Septic Shock Patients Requiring CRRT
A study testing oXiris Hemofilter in people with Septic Shock and Acute Kidney Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether continuous renal replacement therapy (CRRT) using the oXiris filter can lower the amount of endotoxin in the blood of adults with septic shock who need CRRT. Septic shock is a life-threatening condition caused by infection and severe organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Kidney Injury
- What is being tested?
- oXiris Hemofilter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 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 or older.
- Diagnosis of septic shock according to Sepsis-3 criteria: sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure of at least 65 mmHg and a blood lactate level greater than 2 mmol/L despite adequate fluid resuscitation.
- Acute kidney injury classified as KDIGO stage 2 or 3.
- A clinical decision by the treating team to initiate continuous renal replacement therapy (CRRT).
Who cannot join
- The decision to initiate CRRT was made 24 hours or more before enrollment.
- A documented decision to limit life-sustaining treatment or not to pursue invasive treatment.
- Active major bleeding, a major bleeding event within the previous 48 hours, or severe uncorrected bleeding tendency.
- Confirmed or suspected heparin-induced thrombocytopenia, or a known severe allergy to heparin or the filter materials.
- Severe irreversible end-stage organ failure with an expected survival of 48 hours or less.
- Pregnancy or breastfeeding.
- Participation within the previous 6 months in another interventional study that may affect the outcomes of this study.
- Written informed consent not obtained from the participant or legally authorized representative.
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, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Zhijie He, MD, +8615923831885, wuyouqixian@163.com
Gang Li, Mr., +86 13772090248, ligang66@mail2.sysu.edu.cn
About this study
Official title: Effect of the oXiris Hemofilter on Early Endotoxin Burden in Patients With Septic Shock Requiring Continuous Renal Replacement Therapy: A Single-Center, Prospective, Single-Arm Clinical Trial
The goal of this clinical trial is to learn whether continuous renal replacement therapy (CRRT) using the oXiris filter can lower the amount of endotoxin in the blood of adults with septic shock who need CRRT. Septic shock is a life-threatening condition caused by infection and severe organ dysfunction. CRRT is a form of continuous blood purification used to support the kidneys and manage fluid and waste products. The oXiris filter is designed to provide CRRT while also removing endotoxin and inflammatory substances from the blood.
The main questions this study aims to answer are:
Read more
Does 24 hours of CRRT with the oXiris filter lower blood endotoxin levels compared with levels before treatment? What changes occur in inflammation, organ function, and the need for medicines that raise blood pressure? What medical problems or treatment-related complications occur during the study?
This is a single-center study with no comparison group. About 13 participants will take part, and all participants will receive CRRT with the oXiris filter for a planned period of 24 hours. Other treatments for septic shock, including treatment for infection, fluids, medicines to support blood pressure, and other organ support, will be provided according to the hospital's usual care.
Researchers will:
Collect blood samples before and after the 24-hour oXiris treatment to measure endotoxin and markers of inflammation.
Record blood pressure, blood lactate, circulation, organ function, use of blood pressure medicines, and CRRT treatment information.
Continue selected blood tests and clinical assessments during the first 7 days Record any medical problems, including serious medical problems, during the study.
Check whether participants are alive at 28 days and 90 days after enrollment The study may help researchers better understand the biological effects and safety of the oXiris filter and provide information for larger future studies.
- Conditions
- Septic Shock, Acute Kidney Injury
- Being tested
- oXiris Hemofilter
- Keywords
- oXiris, CRRT, Endotoxin, Sepsis-Associated Acute Kidney Injury
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris HemofilterDevice
Also called oXiris Membrane, Endotoxin- and Cytokine-Adsorbing Hemofilter
The oXiris hemofilter will be integrated into a continuous renal replacement therapy circuit using the Prismaflex system. Continuous venovenous hemofiltration will be performed for a planned duration of 24 hours. The prescribed effluent dose will be 25-30 mL/kg/hour, with a blood flow rate of 100-150 mL/min and a replacement fluid rate of 1,000-1,500 mL/hour. Regional citrate anticoagulation will be preferred unless contraindicated. The filter may be replaced earlier if clotting, increased transmembrane pressure, or other clinical or technical conditions require replacement. Treatment after the planned 24-hour study period will be determined by the treating clinicians according to the participant's clinical condition.
| Study group | Role | What they receive |
|---|---|---|
| oXiris Hemofilter With CRRT | Experimental | Participants will receive CRRT using the oXiris hemofilter in continuous venovenous hemofiltration mode for a planned duration of 24 hours. CRRT settings, anticoagulation, fluid management, antimicrobial treatment, vasopressor support, and other organ support will follow standardized institutional protocols and clinical judgment. Blood samples and clinical assessments will be obtained before treatment and at the end of the 24-hour treatment period to evaluate changes in endotoxin levels, inflammatory markers, hemodynamics, organ function, and treatment-related safety events. Receives: Device: oXiris Hemofilter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Blood Endotoxin Level at 24 Hours
Blood endotoxin concentration will be measured in venous blood using the Limulus amebocyte lysate (LAL) kinetic turbidimetric assay before initiation of oXiris-CRRT and immediately after completion of the planned 24-hour treatment. Change will be calculated as the post-treatment value minus the baseline value. A negative value indicates a reduction in blood endotoxin level.
Measured: Baseline and 24 hours
Secondary outcomes (3)
Intensive Care Unit Length of Stay
The number of days from study enrollment to discharge from the intensive care unit or death in the intensive care unit.
Measured: From enrollment through ICU discharge or death, assessed up to 90 days
All-Cause Mortality at Day 28
The number and percentage of participants who die from any cause within 28 days after enrollment.
Measured: Day 28
All-Cause Mortality at Day 90
The number and percentage of participants who die from any cause within 90 days after enrollment.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start1 Aug 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive a standardized 24-hour course of continuous renal replacement therapy using the oXiris filter in continuous venovenous hemofiltration mode. Clinical and laboratory outcomes will be assessed at prespecified time points before and after treatment, with follow-up through Day 90.
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807410
- Sponsor's protocol ID
- SYSKY-2026-525-02
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the oXiris Hemofilter on Early Endotoxin Burden in Patients With Septic Shock Requiring Continuous Renal Replacement Therapy: A Single-Center, Prospective, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07807410
- Acronym / sponsor ID
- SYSKY-2026-525-02
- Conditions
- Septic Shock, Acute Kidney Injury
- Keywords
- oXiris, CRRT, Endotoxin, Sepsis-Associated Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
The goal of this clinical trial is to learn whether continuous renal replacement therapy (CRRT) using the oXiris filter can lower the amount of endotoxin in the blood of adults with septic shock who need CRRT. Septic shock is a life-threatening condition caused by infection and severe organ dysfunction. CRRT is a form of continuous blood purification used to support the kidneys and manage fluid and waste products. The oXiris filter is designed to provide CRRT while also removing endotoxin and inflammatory substances from the blood.
The main questions this study aims to answer are:
Does 24 hours of CRRT with the oXiris filter lower blood endotoxin levels compared with levels before treatment? What changes occur in inflammation, organ function, and the need for medicines that raise blood pressure? What medical problems or treatment-related complications occur during the study?
This is a single-center study with no comparison group. About 13 participants will take part, and all participants will receive CRRT with the oXiris filter for a planned period of 24 hours. Other treatments for septic shock, including treatment for infection, fluids, medicines to support blood pressure, and other organ support, will be provided according to the hospital's usual care.
Researchers will:
Collect blood samples before and after the 24-hour oXiris treatment to measure endotoxin and markers of inflammation.
Record blood pressure, blood lactate, circulation, organ function, use of blood pressure medicines, and CRRT treatment information.
Continue selected blood tests and clinical assessments during the first 7 days Record any medical problems, including serious medical problems, during the study.
Check whether participants are alive at 28 days and 90 days after enrollment The study may help researchers better understand the biological effects and safety of the oXiris filter and provide information for larger future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive a standardized 24-hour course of continuous renal replacement therapy using the oXiris filter in continuous venovenous hemofiltration mode. Clinical and laboratory outcomes will be assessed at prespecified time points before and after treatment, with follow-up through Day 90.
| Arm | Type | Receives |
|---|---|---|
| oXiris Hemofilter With CRRT | Experimental | Device: oXiris HemofilterParticipants will receive CRRT using the oXiris hemofilter in continuous venovenous hemofiltration mode for a planned duration of 24 hours. CRRT settings, anticoagulation, fluid management, antimicrobial treatment, vasopressor support, and other organ support will follow standardized institutional protocols and clinical judgment. Blood samples and clinical assessments will be obtained before treatment and at the end of the 24-hour treatment period to evaluate changes in endotoxin levels, inflammatory markers, hemodynamics, organ function, and treatment-related safety events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Diagnosis of septic shock according to Sepsis-3 criteria: sepsis with persistent hypotension requiring vasopressors to maintain a mean arterial pressure of at least 65 mmHg and a blood lactate level greater than 2 mmol/L despite adequate fluid resuscitation.
- Acute kidney injury classified as KDIGO stage 2 or 3.
- A clinical decision by the treating team to initiate continuous renal replacement therapy (CRRT).
Key exclusion criteria (8 listed)
- The decision to initiate CRRT was made 24 hours or more before enrollment.
- A documented decision to limit life-sustaining treatment or not to pursue invasive treatment.
- Active major bleeding, a major bleeding event within the previous 48 hours, or severe uncorrected bleeding tendency.
- Confirmed or suspected heparin-induced thrombocytopenia, or a known severe allergy to heparin or the filter materials.
- Severe irreversible end-stage organ failure with an expected survival of 48 hours or less.
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 |
|---|---|---|
| oXiris HemofilterAlso: oXiris Membrane, Endotoxin- and Cytokine-Adsorbing HemofilterThe oXiris hemofilter will be integrated into a continuous renal replacement therapy circuit using the Prismaflex system. Continuous venovenous hemofiltration will be performed for a planned duration of 24 hours. The prescribed effluent dose will be 25-30 mL/kg/hour, with a blood flow rate of 100-150 mL/min and a replacement fluid rate of 1,000-1,500 mL/hour. Regional citrate anticoagulation will be preferred unless contraindicated. The filter may be replaced earlier if clotting, increased transmembrane pressure, or other clinical or technical conditions require replacement. Treatment after the planned 24-hour study period will be determined by the treating clinicians according to the participant's clinical condition. | Device | oXiris Hemofilter With CRRT |
Primary outcome
Change From Baseline in Blood Endotoxin Level at 24 Hours
Time frame: Baseline and 24 hours
Blood endotoxin concentration will be measured in venous blood using the Limulus amebocyte lysate (LAL) kinetic turbidimetric assay before initiation of oXiris-CRRT and immediately after completion of the planned 24-hour treatment. Change will be calculated as the post-treatment value minus the baseline value. A negative value indicates a reduction in blood endotoxin level.
3 secondary outcomes
Intensive Care Unit Length of Stay
Time frame: From enrollment through ICU discharge or death, assessed up to 90 days
All-Cause Mortality at Day 28
Time frame: Day 28
All-Cause Mortality at Day 90
Time frame: Day 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 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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 oXiris Hemofilter in people with Septic Shock and Acute Kidney Injury, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 4 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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 Zhijie He, MD (+8615923831885, wuyouqixian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Blood Endotoxin Level at 24 Hours (time frame: Baseline and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.