SepsisPLAQSIRISNCT06440317
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
An observational study of Sepsis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2026to May 2027
- Phase
- Observational
- 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
Study population: Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units
Who may be able to join
- Patients aged 18 years and older
- Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level > 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation
- Requiring renal replacement therapy according to consensus indications:
- KDIGO stage 3 acute kidney injury with oliguria or anuria persisting for more than 72 hours
- Urea > 40 mmol/L
- Plasma potassium > 5.5 mmol/L despite medical treatment
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- pH < 7.15 (pure metabolic acidosis with PaCO2 < 30 mmHg or mixed acidosis with PaCO2 > 50 mmHg without the possibility of improving alveolar ventilation)
- Acute pulmonary edema secondary to hydrosaline overload resulting in severe hypoxemia (oxygen flow > 5 L/min or FiO2 > 50% during mechanical ventilation to maintain SaO2 > 95%) despite diuretic therapy
- Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane)
Who cannot join
- Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
- Myelodysplastic or myeloproliferative syndrome
- Autoimmune thrombocytopenic purpura
- Acute leukemia
- Hemorrhagic shock
- Platelet transfusion within 7 days prior to inclusion
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- Antiplatelet therapy with clopidogrel or ticagrelor within 5 days prior to inclusion, prasugrel or dipyridamole within 7 days prior to inclusion
- Active HIV infection or hepatitis B or C
- Pregnant woman
- Not affiliated to a social security system or not benefiting from such a system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Haut-Lévêque
Pessac, 33604
Antoine DEWITTE, Dr, 05 57 65 68 66 ext. +33, antoine.dewitte@u-bordeaux.fr
Sarah CRONIER, 05 57 65 68 66 ext. +33, sarah.cronier@chu-bordeaux.fr
About this study
Official title: Investigation of Immunothrombosis in Intensive Care Patients With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis.
- Conditions
- Sepsis
- Being tested
- Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)
- Keywords
- Intensive Care, Immunothrombosis, NETs, Neutrophils, Platelets
- Medical subject headings
- Sepsis, Thromboinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)Device
The PRISMAFLEX® or PRISMAX® control unit (pre- and post-dilution with a prescribed treatment dose > 25 ml/kg/h) with regional citrate anticoagulation and a substitution solution by PHOXILLUM will be used regardless of the type of membrane used (the oXiris membrane and the HF 1400 membrane), also as part of routine care provided in the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) | Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units. Receives: Device: Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunothrombosis : Concentration of platelet activation markers
Dosages of platelet activation markers, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
Measured: 12 months after inclusion day
Secondary outcomes (2)
NETosis : Concentration of Neutrophil Extracellular Traps
Dosages of Neutrophil Extracellular Traps, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
Measured: 12 months after inclusion day
Monocyte activation : Concentration of monocyte (CD14+)
Dosages of monocyte (CD14+), before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
Measured: 12 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Maria MAMANI, Pr, Study chair, ImmunoConcEpT, Bordeaux University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440317
- Sponsor's protocol ID
- CHUBX 2023/93
- Acronym
- PLAQSIRIS
- Status last verified
- Jan 2026
- First submitted
- 25 Apr 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Immunothrombosis in Intensive Care Patients With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
- ClinicalTrials.gov ID
- NCT06440317
- Acronym / sponsor ID
- PLAQSIRIS / CHUBX 2023/93
- Conditions
- Sepsis
- Keywords
- Intensive Care, Immunothrombosis, NETs, Neutrophils, Platelets
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Jun 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.
Sepsis remains a global scourge. Before the SARS-CoV-2 pandemic, the World Health Organization estimated approximately 49 million cases annually, resulting in 11 million deaths. Defined by dysregulated host response to infection, sepsis leads to vital organ failure. Renal dysfunction affects about half of ICU patients, necessitating extracorporeal renal replacement therapy in approximately 10% of cases, alongside coagulation system involvement typified by thrombocytopenia. Immunothrombotic phenomena are pivotal in sepsis pathophysiology, activating coagulation and disrupting immune responses. Microcirculatory impairment, mediated by neutrophils, monocytes, and platelets, worsens vital organ perfusion. Excessive production of Neutrophil Extracellular Traps (NETs) is implicated in microcirculatory compromise during sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) | – | Device: Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units
Key inclusion criteria (9 listed)
- Patients aged 18 years and older
- Admitted to the intensive care unit with septic shock, defined as an increase in the Sequential Organ Failure Assessment (SOFA) score of at least 2 points due to infection, requiring vasopressor drugs to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a lactate level > 2 mmol/L (18 mg/dL) despite adequate fluid resuscitation
- Requiring renal replacement therapy according to consensus indications:
- Receiving continuous renal replacement therapy with a high-adsorption membrane (oXiris membrane) or a conventional membrane (HF1400 membrane)
Key exclusion criteria (10 listed)
- Known history of constitutional thrombopathy (Bernard Soulier disease, Glanzmann thrombasthenia, Gray's syndrome or dense granule disease)
- Myelodysplastic or myeloproliferative syndrome
- Autoimmune thrombocytopenic purpura
- Acute leukemia
- Hemorrhagic shock
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 |
|---|---|---|
| Hemofiltration membranes (the oXiris membrane® and the HF1400® membrane)The PRISMAFLEX® or PRISMAX® control unit (pre- and post-dilution with a prescribed treatment dose > 25 ml/kg/h) with regional citrate anticoagulation and a substitution solution by PHOXILLUM will be used regardless of the type of membrane used (the oXiris membrane and the HF 1400 membrane), also as part of routine care provided in the ICU. | Device | Hemofiltration membranes (the oXiris® membrane and the HF1400 ® membrane) |
Primary outcome
Immunothrombosis : Concentration of platelet activation markers
Time frame: 12 months after inclusion day
Dosages of platelet activation markers, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
2 secondary outcomes
NETosis : Concentration of Neutrophil Extracellular Traps
Time frame: 12 months after inclusion day
Monocyte activation : Concentration of monocyte (CD14+)
Time frame: 12 months after inclusion day
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 15 Jan 2026.
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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.
Maria MAMANI, Pr study chair
ImmunoConcEpT, Bordeaux University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University Hospital, Bordeaux at 1 site in France.
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 9 inclusion and 10 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 15 Jan 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 France. 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 Antoine DEWITTE, Dr (05 57 65 68 66 ext. +33, antoine.dewitte@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunothrombosis : Concentration of platelet activation markers (time frame: 12 months after inclusion day). 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 15 Jan 2026; AzTrials last refreshed its copy on 1 Nov 2026.