NCT04963920暂停不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 260
- 试验地点
- 18
- 主要终点
- Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline
研究概览
简要总结
To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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])
排除标准
- •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
研究组 & 干预措施
SoC+CytoSorb treatment
Experimental
patients allocated to this group, will receive CytoSorb therapy in addition to the standard of care therapy according to applicable guidelines
干预措施: Cytosorb® 300 ml (Device)
Standard of Care (SoC)
No Intervention
patients allocated to this group will receive only standard of care therapy according to applicable guidelines
结局指标
主要结局
Percentage change in noradrenaline (NA) dose 24 hours after baseline, assessed as mean over the time window 22 to 26 hours after baseline
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (18)
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