Extracorporal Cytokin Removal in Septic Shock: a Prospective, Randomized, Multicenter Clinical Trial

NCT04742764 | Suspended Phase 3 DMC

• 1 other identifier: OGYÉI/65049/2020
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis and septic shock have mortality rates between 20-50%. When standard therapeutic measures fail to improve patients' condition, additional therapeutic alternatives are applied to reduce morbidity and mortality. One of the most recent alternatives is extracorporeal cytokine hemoadsorption. One of the most tested devices is CytoSorb, however, there are a lot of open questions, such timing, dosing and of course its overall efficacy. This study aims to compare the efficacy of standard medical therapy (Group A, SMT) and continuous extracorporeal cytokine removal with CytoSorb therapy in patients with early refractory septic shock. Furthermore, we compare the dosing of CytoSorb adsorber device - as the cartridge will be changed in every (12 Group B) or 24 hours (Group C).

Conditions

Septic Shock

Keywords

sepsis, septic shock, cytosorb, cytokine removal

Outcome Measures

Primary Outcomes (2)

• Shock reversal

  Proportion of patients achieving shock reversal, defined as follows: no need (or minimal need, meaning max. the 10% of the maximum dose) of vasopressore for 3 hours, with haemodynamic measurements, and arterial, central venous blood gas analysis, arterial lactate level measurement, venous and arterial pCO2-gap and O2 saturation measurements to confirm cardiorespiratory stability

  At the time of shock reversal assessed up to 5 days

• Time to shock reversal

  The time from the start of the treatment (T0) until shock reversal

  From the start of the treatment until shock reversal assessed up to 5 days

Secondary Outcomes (32)

• Procalcitonine level

  0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit

• Change in procalcitonine level

  0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit

• Interleukin-6 level

  0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit

• Change in interleukin-6 level

  0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit

• C-reactive protein level

  0, 6, 12,24 hours after the start of the treatment, then daily until the end of study period assessed up to 90 +/- 7 days at second follow-up visit

Study Arms (3)

Group A

ACTIVE COMPARATOR

Patients randomized to standard medical therapy.

Combination Product: Standard medical therapy

Group B

ACTIVE COMPARATOR

Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 12 hours.

Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours

Group C

ACTIVE COMPARATOR

Patients randomized to cytokine removal therapy with Cytosorb, with the adsorber device changed in every 24 hours.

Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours

Interventions

Standard medical therapy COMBINATION_PRODUCT

Standard medical therapy (according to the Surviving Sepsis Campaign) will include standard monitoring (pulseoximetry, 5-lead ECG, continuous invasive blood pressure monitoring, central venous cannulation and 24 with PiCCO-technology. Norepinephrine as a vasopressor and dobutamine - if needed - as an inotrope will be administered by the attending physician.

Group A

Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours DEVICE

Standard medical therapy, as discussed above will be applied. Furthermore, Cytosorb will be administered as soon as it is possible after randomization but not later than 2 hour (start of the treatment, T0). In a blood pump circuit in pre-haemofilter position, using a kidney replacement device of Fresenius Multifiltrate as a solo therapy or in combination with renal replacement therapy. It will be run in CVVHD, CVVHDF or CVVH mode with a 150 and 200 ml/min blood flow. Anticoagulation will be applied intravenously with heparin, low molecular weight heparin or citrate. The aim of the pump flow rate will be 100-400 mL/min, and the flow rate will be recorded. Possible shock reversal will be assessed by the physician attending. Adsorber cartridges will be changed in every 12 hours. End of the study period (Te): 12 hours after shock reversal, death of the patient, or maximum of five days, whichever happens first.

Group B

Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours DEVICE

The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.

Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Septic shock as defined by the Sepsis-3 criteria
• Septic shock both medical or surgical ethiology (except for re-operation)
• APACHE \> 25
• Mechanical ventilation
• Norepinephrine requirement ≥0.4 µg/kg/min for at least 30 minutes, when hypovolemia is highly unlikely as indicated by invasive hemodynamic measurements assessed by the attending physician
• Invasive hemodynamic monitoring to determine cardiac output and derived variables
• Procalcitonin level ≥ 10 ng/ml

You may not qualify if:

• Patients under 18 years and over 80
• Lack of health insurance
• Pregnancy
• Standard guideline-based medical treatment not exhausted (detailed below at 3.6) standard medical therapy)
• End stage organ failure
• New York Heart Association Class IV.
• Chronic renal failure with eGFR \< 15 ml/min/1,73 m2
• End-stage liver disease (MELD score \>30, Child-Pugh score Class C
• Unlikely survival for 24 hours according to the attending physician
• Acute onset of hemato-oncological illness
• Post cardiopulmonary resuscitation care
• Re-operation in context with the septic insult
• Immunosuppression
• systemic steroid therapy (\>10 mg prednisolon/day)
• immunosuppressive agents (i.e.: methotrexate, azathioprine, cyclosporin, tacrolimus, cyclophosphamide)

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Institute for Translational Medicine, University of Pécs

Pécs, 7624, Hungary

Location

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MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: No masking is applied in this study, as it is impossible to blind the medical personnel and participants. Statisticians will be blinded to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, three-arm, open-label, international, multi-centre, phase III study

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 8, 2021
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 20, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)