Status:
COMPLETED
Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™
Lead Sponsor:
Hospices Civils de Lyon
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Septic Shock
Peritonitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sepsis is a major cause of death in Intensive Care Units and therefore finding new therapies to improve survival rates and limit morbidity is a major goal. Over the past decades, blood purification ha...
Eligibility Criteria
Inclusion
- Male or female aged ≥ 18 years old,
- "Early" septic shock (in the first 12 hours after Intensive Care Unit (ICU) admission or readmission in the ICU after surgery), with lactatemia \> 2 mmol/L and norepinephrine needs \> 0.2 µg/kg/min 2 hours after the end of the initial surgery (to ensure that a potential anesthesia effect as disappeared),
- Secondary to a community-acquired or a nosocomial peritonitis (secondary or tertiary but not primary peritonitis),
- AKI KDIGO ≥ stage 2 or another indication for renal replacement therapy, according to the clinician in charge (if baseline creatinine is unknown, KDIGO ≥ stage 2 can be defined by a serum creatinine ≥ 2-fold the normal creatinine for age, gender, and ethnicity).
Exclusion
- Inability to obtain informed consent from the patient or next of kin,
- Actual participation in another interventional study,
- Contraindications to citrate,
- Allergy to heparin,
- Pregnant or breastfeeding woman,
- Neutropenia \< 0.5 G/L resulting from chemotherapy or other iatrogenic causes
- Patient receiving immunosuppressive therapy, long-term corticosteroids, therapeutic antibodies, chemotherapy in the last 6 months (whatever the dose),
- Patient with innate or acquired immune deficiency (for example severe combined immunodeficiency, HIV or AIDS)
- Onco-hematological disease (lymphoma, leukemia, myeloma) treated within the last 5 years (but inclusion of a patient with solid cancer who did not receive chemotherapy during the past 6 months is possible),
- Patient with expected ICU length of stay \< 48 hours,
- Patient for whom a limitation of active care was pronounced at the time of enrollment,
- Patient with no social security insurance, with restricted liberty, or under legal protection.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2022
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03426943
Start Date
December 21 2018
End Date
June 3 2022
Last Update
December 5 2023
Active Locations (8)
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1
Hopital Universitaire de Clermont Ferrand
Clermont-Ferrand, France, 63003
2
CHU Francois Mitterrand
Dijon, France, 21033
3
CHU Dijon - Bocage central
Dijon, France, 21079
4
L'Hôpital Nord-Ouest - Villefranche sur Saone
Gleizé, France, 69400