jRCT1012260032尚未招募不适用
A single-center, prospective, open-label, parallel-group pilot randomized controlled trial of granulocyte and monocyte adsorption therapy with Adacolumn in ICU patients with sepsis (Adacolumn Pilot RCT)
未提供0 个研究点目标入组 60 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age 18 years or older.
- •Admitted to the intensive care unit.
- •Sepsis according to the Sepsis-3 criteria, defined as suspected or confirmed
- •infection with an increase in the SOFA score of 2 points or more attributable
- •to infection.
- •Able to be enrolled within 24 hours after ICU admission, diagnosis of sepsis,
- •or diagnosis of septic shock.
- •At least one of the following:
- •Requirement for vasopressors.
- •Requirement for invasive mechanical ventilation.
- •Requirement for renal replacement therapy, or presence of acute kidney injury.
- •SOFA score of 6 points or more.
- •Written informed consent obtained from the patient or a legally acceptable
- •representative.
排除标准
- •Judged by the attending investigator to have irreversible end-stage multiple
- •organ failure.
- •Treatment limitation, do-not-attempt-resuscitation order, or comfort care
- •policy already established at the time of enrollment.
- •Receiving long-term mechanical ventilation or maintenance dialysis before
- •enrollment.
- •Difficulty in obtaining vascular access.
- •Severe circulatory failure precluding extracorporeal circulation.
- •Severe bleeding tendency or contraindication to anticoagulation.
- •Severe leukopenia (neutrophil count less than 500/microliter).
- •Pregnancy or possible pregnancy.
- •Judged inappropriate by the principal investigator or a sub-investigator.
研究者
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