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

University of Pecs

Status and phase: Suspended; Phase 3

Conditions: Septic Shock

Treatments: Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours; Device: Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours; Combination Product: Standard medical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04742764

OGYÉI/65049/2020

Details and patient eligibility

About

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).

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Inclusion within 6 - 24 hours after the onset of vasopressor need and after all standard therapeutic measures have been implemented without clinical improvement (i.e.: the shock is considered refractory)

Exclusion criteria

• 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)
• Human immunodeficiency virus infection (active AIDS): HIV-VL > 50 copies/mL
• Patients with transplanted vital organs
• Thrombocytopenia (<20.000/ml)
• More than 10%-of body surface area with a third-degree burn
• Acute coronary syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Group A

Active Comparator group

Description:

Patients randomized to standard medical therapy.

Treatment:

Combination Product: Standard medical therapy

Group B

Active Comparator group

Description:

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

Treatment:

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

Group C

Active Comparator group

Description:

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

Treatment:

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