Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane (PLAQSIRIS)

January 13, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible patients for this study will undergo renal replacement therapy using two hemofiltration membranes commonly used in intensive care units

Description

Inclusion Criteria:

  • 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
    • 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)

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months after inclusion day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NETosis : Concentration of Neutrophil Extracellular Traps
Time Frame: 12 months after inclusion day
Dosages of Neutrophil Extracellular Traps, before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
12 months after inclusion day
Monocyte activation : Concentration of monocyte (CD14+)
Time Frame: 12 months after inclusion day
Dosages of monocyte (CD14+), before and after the renal replacement therapy membrane : oXiris membrane or conventional membrane
12 months after inclusion day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Baxter Healthcare Corporation

Investigators

  • Study Chair: Maria MAMANI, Pr, ImmunoConcEpT, Bordeaux University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2023/93

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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