A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock

Study Overview
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Brief Summary
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To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.

Official Title
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A Prospective, Randomized, Multicenter, Single-blind, Controlled Study to Assess the Performance of the Cytosorb® 300 ml Device for Shock Reversal in Patients With Vasoplegic Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Device: Cytosorb® 300 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for > 6 and < 30 hours prior to randomization Vasoplegic septic shock*, requiring NA ≥ 0.2 µg/kg/min at the time of randomization, despite adequate fluid resuscitation to maintain MAP ≥ 65 mmHg after at least 6 hours of guideline-oriented initial therapy, including continuous NA administration Lactate >2 mmol/l and <8 mmol/l at baseline IL-6 ≥ 1000 ng/l at screening Minimum 18 years of age Provide voluntary consent to participate in the study either directly or via a legally authorized representative (LAR) or in accordance to the procedure after determination of an emergency situation according to Art. 68 (1) MDR, as applicable (Septic shock is defined according to the SCCM / EISCM task force Sepsis-3 definition [Singer 2016]) Exclusion Criteria: Patients with an abdominal source of infection without a source control intervention at the time of randomization OR a planned additional surgical intervention within the first 28 hours after randomization Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization Patients with a steroid therapy above Cushing-threshold dose (e.g. 30 mg hydrocortisone/d or 6 mg prednisolone/d) for more than 30 days prior to baseline Cytokine-specific antibody therapy before inclusion Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention Conditions with a poor 90-day chance of survival because of an uncorrectable medical condition such as poorly controlled neoplasm, or other moribund end-stage disease states in which death was perceived to be imminent Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors) Acute traumatic brain injury Decision to limit or withdraw treatment within the study and/or observation period in the ICU Pregnancy / breast feeding Participation in another interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SoC+CytoSorb treatment<br>patients allocated to this group, will receive CytoSorb therapy in addition to the standard of care therapy according to applicable guidelines | Device: Cytosorb® 300 ml<br>* patients will receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines<br>|
| No Intervention: Standard of Care (SoC)<br>patients allocated to this group will receive only standard of care therapy according to applicable guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline |  | 24 hours |