Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03426943
• Date of registration: 02/02/2018
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™ ECRO
• Scientific title: Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™
• Date of first enrolment: December 21, 2018
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03426943
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Thomas RIMMELE, MD, PhD
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peritonitis

Septic Shock

Intervention(s)

Device: CVVH using oXiris™ filter

Biological: Arterial blood sampling

Biological: Ultrafiltrate sampling

Device: CVVH using PrismafleX HF1400 filter

Primary Outcome(s)

Endotoxin plasmatic mass concentration [Time Frame: 24 hours after the initiation of CVVH]

Interleukin 6 (IL-6) plasmatic concentration [Time Frame: 24 hours after the initiation of CVVH]

Secondary Outcome(s)

Pre-filter plasma endotoxin mass [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Patient survival [Time Frame: At day 30]

Patient survival [Time Frame: At day 7]

Pre-filter plasma lipids level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma Procalcitonin level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Patient survival [Time Frame: At day 90]

Post-filter plasma endotoxin activity [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Pre-filter plasma endotoxin activity [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Comparison of the results obtained on the above-mentioned parameters, according to the type of bacteria identified from standard care microbiological exams. [Time Frame: At day 7]

Pre-filter plasma cytokine level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma Cholesteryl Ester Transfer Protein level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Fluids infused [Time Frame: 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma Phospholipid Transfer Protein level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma cytokine level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma LPS-Binding Protein level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Pre-filter plasma Cholesteryl Ester Transfer Protein level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Norepinephrine requirements [Time Frame: 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma endotoxin mass [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Pre-filter plasma Procalcitonin level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Pre-filter plasma Phospholipid Transfer Protein level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Post-filter plasma lipids level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Pre-filter plasma lipopolysaccharide (LPS) Binding Protein level [Time Frame: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH]

Ultrafiltrate cytokine level [Time Frame: 1, 4, 12 and 24 hours after the initiation of CVVH]

Secondary ID(s)

2017-A03366-47

69HCL17_0014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Baxter Healthcare Corporation