INSPiRE-ICU 1 & 2: A Pooled Analysis of Long-Term Outcomes at 3 and 6 Months After Inhaled Isoflurane Delivered Via the Sedaconda ACD-S Compared to Intravenous Propofol for Sedation of Mechanically Ventilated Intensive Care Unit Adult Patients
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients
研究概览
简要总结
This pooled analysis will assess Cognitive, Mental Health, Functioning, and Quality of Life Assessments data from the Phase 3 registration studies INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296) to explore potential differences in Long-Term Outcomes at 3 and 6 months after treatment between critically ill mechanically ventilated patients sedated with inhaled isoflurane compared to sedated with intravenous propofol.
The analyses were pre-planned and agreed prior to completion of enrollment of either study.
详细描述
SED003 and SED004 are two Phase 3 studies conducted in the US, with a goal to demonstrate non-inferiority of isoflurane administered via Sedaconda ACD-S to the current standard of care (SOC), IV propofol infusion, in patients requiring sedation and mechanical ventilation in the ICU.
These studies are therapeutic confirmatory (Phase 3), multicenter, randomized, controlled, open-label, assessor-blinded studies. Approximately 470 patients receiving mechanical ventilation and requiring continuous sedation at approximately 30 sites in total in the United States (US) will be randomized in a 1.5:1 ratio to inhaled isoflurane (administered via the Sedaconda ACD-S device) or propofol (administered via IV infusion) for sedation, respectively. In addition, approximately 3 to 5 run-in training patients per site will be enrolled. The treatment duration is expected to be at least 12 hours and may last up to 48 (±6) hours or to the time for extubation, whichever occurs first, with a follow up period of 6 months.
Patients eligible for the studies will either have planned surgery with anticipated need for sedation and mechanical ventilation in the ICU (ie, postoperative patients) for >12 hours or have already been admitted to the ICU and anticipate needing sedation and mechanical ventilation for >12 hours.
For further information about the studies, refer to INSPiRE-ICU 1 (NCT05312385) and INSPiRE-ICU 2 (NCT05327296).
In drug studies of critically ill patients, outcomes may be assessed at remote timepoints and not merely in the ICU. This is because the "success" of interventions is not defined merely by their impact in the hospital but also by their persistent effects. The CIBS Center at Vanderbilt University Medical Center will conduct the long-term outcome assessments for a subset of patients in the INSPiRE-ICU studies.
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 (Outcomes Assessor)
盲法说明
For the Long-term follow-up part of the INSPiRE-ICU 1 & 2 studies, a separate centralized team at the Critical Illness, Brain Dysfunction and Survivorship (CIBS) center at Vanderbilt University Medical Center, is conducting the assessments and are not informed about the study treatment patients received at their respective site.
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 who are enrolled in INSPiRE-ICU1 (NCT05312385) or INSPiRE-ICU2 (NCT05327296) and survived to discharge.
排除标准
- 未提供
研究组 & 干预措施
Inhaled isoflurane administered via Sedaconda ACD-S
Intervention: isoflurane
干预措施: Inhaled isoflurane administered by Sedaconda ACD-S (Drug)
Propofol administered as intravenous infusion
Treatment: propofol
干预措施: Intravenous infusion of propofol (Drug)
结局指标
主要结局
To compare cognitive function 3 months post randomization in isoflurane- vs propofol-treated patients
时间窗: 3 months post Randomization
A patient is classified as cognitive impaired if the patient has a score 2 SD (or more) worse than population mean for one test or has a score 1.5 SD (or more) worse than population mean in two or more of the following tests: TICS, WAIS IV Digit Span, Hayling Sentence Completion Test, Controlled Oral Word Association, WMS IV - Immediate Memory (Adult/Older Adult) and WMS IV - Delayed Memory (Adult/Older Adult), at 3 months post randomization. The analysis will take into account age, sex, level of education, total IQCODE score at baseline, total SAPS total score at baseline, medical or surgical admission duration of mechanical ventilation before randomization, study drug and treatment duration as factors.
次要结局
- To compare memory panorama from time in the ICU in isoflurane- vs propofol-treated patients(3 months post Randomization)
- To compare physical outcomes and trajectories at 3 and 6 months post randomization in isoflurane- vs propofol-treated patients(3 and 6 months post Randomization)
- To compare depressive symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients(3 months post Randomization)
- To compare anxiety symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients(3 months post Randomization)
- To compare post-traumatic stress symptoms at 3 months post randomization in isoflurane- vs propofol-treated patients(3 months post Randomization)
- To compare quality of life at 3 months post randomization in isoflurane- vs propofol-treated patients(3 months post Randomization)