ClinicalTrials.Gov PRS Field-by-Field Checklist & Results Module Templates - REMIMID-ICU
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Percentage of time within target sedation without rescue
研究概览
简要总结
This trial evaluates whether remimazolam provides superior sedation quality compared with midazolam in adults receiving invasive mechanical ventilation with ongoing vasopressor support. The primary outcome is the percentage of time within target sedation (RASS -3 to -5) without rescue sedative during the first 48 hours after randomization. Key secondary outcomes include vasopressor exposure (NEE AUC 0-48h), time to awakening, delirium incidence, ventilator-free days, and 28-day mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A - Remimazolam
Continuous IV infusion; start 0.10 mg/kg/h and titrate every 15-30 minutes in 0.025-0.05 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5 for clinical safety). Maximum typical rate 0.20 mg/kg/h; temporary higher rates permitted per protocol for breakthrough agitation.
干预措施: Remimazolam Besylate (Drug)
Arm B - Midazolam
Continuous IV infusion; start 0.04 mg/kg/h and titrate every 15-30 minutes in 0.01-0.03 mg/kg/h steps to target RASS -3 to -5 (allowable range -2 to -5). Maximum typical rate 0.20 mg/kg/h per protocol.
干预措施: Midazolam (Drug)
结局指标
主要结局
Percentage of time within target sedation without rescue
时间窗: 0-48 hours post-randomization
Proportion (%) of all valid RASS assessments that are within -3 to -5 with no rescue sedative in the prior 60 minutes, during 0-48h after randomization.
次要结局
未报告次要终点
研究者
Wang Yiqiu
graduate student
Yancheng First People's Hospital