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Septic ShockECRONCT03426943

Endotoxins and Cytokines Removal During Continuous Hemofiltration With oXiris™

A study testing Arterial blood sampling, Ultrafiltrate sampling and CVVH using oXiris™ filter in people with Septic Shock and Peritonitis, run by Hospices Civils de Lyon at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 has been proposed as an adjuvant therapy for sepsis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Septic Shock, Peritonitis
What is being tested?
Arterial blood sampling, Ultrafiltrate sampling and CVVH using oXiris™ filter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesFrance
Study dates
21 Dec 2018to 3 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Hopital Universitaire de Clermont Ferrand

    Clermont-Ferrand, 63003

  • CHU Francois Mitterrand

    Dijon, 21033

  • CHU Dijon - Bocage central

    Dijon, 21079

  • L'Hôpital Nord-Ouest - Villefranche sur Saone

    Gleizé, 69400

  • Anesthesia and Critical Care Medicine Department - Edouard Herriot Hospital

    Lyon, 69003

  • Clinique de la Sauvegarde

    Lyon, 69337

  • Hôpital Pasteur 2 - Hôpital Universitaire de Nice

    Nice, 06000

  • Hopital Haut Lévèque - CHU Bordeaux

    Pessac, 33600

Other trials in France

About this study

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 has been proposed as an adjuvant therapy for sepsis. The goal of blood purification is to restore the immune homeostasis and efficiency through the removal of bacterial products including endotoxins, broad-spectrum cytokines and other inflammatory mediators. Indeed, the large and overwhelmed release of these mediators in the early phase of sepsis may induce multiple organ failure syndrome. In 2017, different techniques are proposed for blood purification. Among them, the highly adsorptive membrane, oXiris™, seems promising. This membrane can be used in case of Acute Kidney Injury associated with sepsis and exhibits enhanced blood purification capacities. Previous studies on animals have already proven that this membrane can remove broad-spectrum cytokines but also endotoxins from the blood. This ability to remove endotoxins is particularly interesting since endotoxins are believed to be the trigger of the immune cascade at the initiation of sepsis.

The lack of clinical evidence is the main limit to a wider use of this membrane. Therefore, the aim of the present clinical trial is to characterize the blood purification properties of the membrane in a human clinical setting. The oXiris™ membrane is specifically designed to improve the adsorptive capacities of the polyacrylonitrile-based AN69 membrane. Its extremely rich coating of polyethyleneimine (PEI) gives the membrane the ability to bind and remove not only cytokines but also endotoxins due to the positive charges of PEI at the surface of the membrane. The tested hypothesis is that the oXiris™ filter allows for a greater endotoxin and cytokine removal compared to a standard polysulfone ("PrismafleX HF1400") filter in patients with septic shock.

Being tested
Arterial blood sampling, Ultrafiltrate sampling, CVVH using oXiris™ filter, CVVH using PrismafleX HF1400 filter
Medical subject headings
Shock, Septic, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arterial blood samplingBiological

    All patients will have arterial blood sampling to assess pre-filter and post-filter plasma endotoxin mass and activity and plasma cytokine levels

  • Ultrafiltrate samplingBiological

    All patients will have ultrafiltrate sampling to assess cytokine levels

  • CVVH using oXiris™ filterDevice

    Patients included in the experimental arm will have renal replacement therapy by performing CVVH using oXiris™ filter

  • CVVH using PrismafleX HF1400 filterDevice

    Patients included in the experimental arm will have renal replacement therapy by performing CVVH using PrismafleX HF1400 filter

Study groups in NCT03426943
Study groupRoleWhat they receive
CVVH using oXiris™ filterExperimentalPatients included in this arm will have renal replacement therapy by performing Continuous Veno-Venous Hemofiltration (CVVH) using oXiris™ membrane. They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH.
Receives: Biological: Arterial blood sampling; Biological: Ultrafiltrate sampling; Device: CVVH using oXiris™ filter
CVVH using PrismafleX HF1400 filterActive comparatorPatients included in this arm will have renal replacement therapy by performing CVVH using a standard polysulfone filter (PrismafleX HF1400). They will also have arterial blood sampling and ultrafiltrate sampling during the CVVH.
Receives: Biological: Arterial blood sampling; Biological: Ultrafiltrate sampling; Device: CVVH using PrismafleX HF1400 filter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interleukin 6 (IL-6) plasmatic concentration

    Measured: 24 hours after the initiation of CVVH

  2. Endotoxin plasmatic mass concentration

    Measured: 24 hours after the initiation of CVVH

Secondary outcomes (23)

  1. Pre-filter plasma endotoxin mass

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  2. Pre-filter plasma endotoxin activity

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  3. Post-filter plasma endotoxin mass

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  4. Post-filter plasma endotoxin activity

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  5. Pre-filter plasma cytokine level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  6. Post-filter plasma cytokine level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  7. Ultrafiltrate cytokine level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  8. Pre-filter plasma lipids level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  9. Post-filter plasma lipids level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  10. Pre-filter plasma Procalcitonin level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  11. Post-filter plasma Procalcitonin level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  12. Pre-filter plasma Phospholipid Transfer Protein level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  13. Post-filter plasma Phospholipid Transfer Protein level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  14. Pre-filter plasma Cholesteryl Ester Transfer Protein level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  15. Post-filter plasma Cholesteryl Ester Transfer Protein level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  16. Pre-filter plasma lipopolysaccharide (LPS) Binding Protein level

    Measured: At initiation of CCVH (H0) then 1, 4, 12 and 24 hours after the initiation of CVVH

  17. Post-filter plasma LPS-Binding Protein level

    Measured: 1, 4, 12 and 24 hours after the initiation of CVVH

  18. Norepinephrine requirements

    Measured: 4, 12 and 24 hours after the initiation of CVVH

  19. Fluids infused

    Measured: 4, 12 and 24 hours after the initiation of CVVH

  20. Patient survival

    Measured: At day 7

  21. Patient survival

    Measured: At day 30

  22. Patient survival

    Measured: At day 90

  23. Comparison of the results obtained on the above-mentioned parameters, according to the type of bacteria identified from standard care microbiological exams.

    Measured: At day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2018
  2. Study start21 Dec 2018
  3. Primary completion3 Jun 2022
  4. Study completion3 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03426943
Sponsor's protocol ID
69HCL17_0014
Other IDs
2017-A03366-47
Acronym
ECRO
Status last verified
Oct 2022
First submitted
2 Feb 2018
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

    PubMed 34519356

Questions about this trial

What is this clinical trial studying?

A study testing Arterial blood sampling, Ultrafiltrate sampling and CVVH using oXiris™ filter in people with Septic Shock and Peritonitis, run by Hospices Civils de Lyon at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interleukin 6 (IL-6) plasmatic concentration (time frame: 24 hours after the initiation of CVVH). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03426943, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.

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