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

Launched by CYTOSORBENTS EUROPE GMBH · Jul 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a device called CytoSorb® to see if it can help improve the condition of patients suffering from a serious illness known as vasoplegic septic shock. Septic shock occurs when an infection leads to dangerously low blood pressure and organ failure. The trial is looking for adults aged 18 and older who have been receiving standard treatment for septic shock for at least 6 hours but less than 30 hours. Key eligibility requirements include having specific levels of a substance called lactate and a protein called IL-6 in the blood, as well as needing a medication called norepinephrine to maintain blood pressure.

Participants in this trial will receive the CytoSorb® treatment along with their standard care. The goal is to see if using this device can help reverse the shock and improve their recovery. It’s important to note that certain individuals, such as those with specific types of infections or on certain medications, may not be eligible to participate. If you or a loved one is facing septic shock and might be interested in this study, it’s a good idea to discuss it with a healthcare provider to understand more about the potential benefits and risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for \> 6 and \< 30 hours prior to randomization
• • 2. 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
• • 3. Lactate \>2 mmol/l and \<8 mmol/l at baseline
• • 4. IL-6 ≥ 1000 ng/l at screening
• • 5. Minimum 18 years of age
• • 6. 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:
• • 1. 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
• • 2. Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization
• • 3. Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization
• • 4. 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
• • 5. Cytokine-specific antibody therapy before inclusion
• • 6. Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention
• • 7. 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
• • 8. Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors)
• • 9. Acute traumatic brain injury
• • 10. Decision to limit or withdraw treatment within the study and/or observation period in the ICU
• • 11. Pregnancy / breast feeding
• • 12. Participation in another interventional study