Investigating immunothrombosis in septic shock patients needing kidney support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with septic shock who require renal replacement therapy. It aims to understand the role of immunothrombosis in sepsis, particularly how neutrophils and platelets contribute to organ dysfunction. The study will utilize specific hemofiltration membranes, including the oXiris membrane, to assess their impact on coagulation and immune responses in these critically ill patients. By analyzing the effects of these interventions, the study seeks to provide insights into improving patient outcomes in sepsis management.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Haut-Lévêque
  Pessac, France Recruiting

Study contacts

• Study coordinator: Antoine DEWITTE, Dr
• Email: antoine.dewitte@u-bordeaux.fr
• Phone: 05 57 65 68 66

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.