Investigating immunothrombosis in septic shock patients needing kidney support
Investigation of Immunothrombosis in Intensive Care Patients With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
This study is trying to see how a special type of blood filter can help patients with septic shock and kidney problems by looking at how their immune system and blood clotting work together.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Trial ID | NCT06440317 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU with septic shock and require renal replacement therapy.
Not a fit: Patients who do not meet the criteria for septic shock or those who are not in need of renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for septic shock patients, potentially enhancing their recovery and survival rates.
How similar studies have performed: Other studies have explored similar approaches in sepsis management, indicating potential for success, though this specific methodology may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pessac
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.