A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic… (NCT04963920) | Clinical Trial Compass
SuspendedNot Applicable
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock
Stopped: Recruitment for the study is currently on hold to allow for a protocol amendment. This revision aims to align the study design with changes in clinical practice since the trial's initiation.
Germany260 participantsStarted 2022-01-30
Plain-language summary
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
What they're measuring
1
Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after 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)