Midodrine for the Early Liberation From Vasopressor Support in the ICU - The LIBERATE Multi-Site Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 870
- 试验地点
- 1
- 主要终点
- Hierarchical composite of 28-day mortality and ICU length of stay
研究概览
简要总结
Vasopressors are medications that are given intravenously to increase the blood pressure of patients with illnesses that cause dangerous blood pressure drops. When a doctor prescribes a vasopressor, they ask that the dose be adjusted to achieve a specific blood pressure. This kind of medical support with intravenous (IV) vasopressors are usual treatments in intensive care unit (ICU) settings. Oral vasopressors, such as midodrine, have been historically used to maintain blood pressure in non-critically ill patients. In this study, the investigators will be using midodrine to reduce the need for IV vasopressors as blood pressure improves during the stay in the ICU.
This LIBERATE multi-site study will continue the work of the LIBERATE feasibility RCT study to evaluate the role of midodrine for patients with low blood pressure in the ICU. It is comprised of the multi centre pilot RCT followed by the definitive multi centre RCT.
详细描述
Purpose: Resuscitation and hemodynamic support with intravenous (IV) vasopressors is a prime indication of treatment in intensive care unit (ICU) settings. Hemodynamic support is typically provided with intravenous (IV) vasopressors. However, these have been shown to have significant negative effects including increased central venous catheter line associated infections, venous thromboembolic disease, impaired mobility and gastrointestinal injury and ischemia. Oral vasopressors, such as midodrine, have been historically used for hemodynamic support in non-critically ill patients, but their study in patients as IV pressor sparing therapy has been limited.
Hypothesis: to evaluate the expanded role of midodrine for any vasoplegic patients in the ICU.
Justification: In 2018, there were 1,613 admissions to the adult general systems ICU (GSICU) at the University of Alberta Hospital (UAH). Patients were sick, with a mean Acute Physiology and Chronic Health Evaluation II (APACHE) score of 21.3, with 36.4% requiring vasopressors on admission, accounting for 1942 patient-days (data from eCritical TRACER database). In the environment strained healthcare resources and limited ICU capacity, the ability to safely wean patients from IV vasopressors with transition to oral hemodynamic supporting agents would greatly improve how patients navigate through the healthcare system. This in turn will improve patient-centered case.
Primary Objective:
To compare the effect of enteral midodrine vs. placebo in critically ill patients with vasoplegia receiving continuous IV vasopressor therapy on a hierarchical composite of 28-day mortality and ICU length of stay.
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
- 是
入选标准
- •Age > 18 years
- •Ongoing vasopressor support
- •Decreasing vasopressor dose(s)
排除标准
- •Greater than 24 hours from peak vasopressor dose
- •Contraindication to enteral medications
- •Previously received midodrine in last 7 days
- •Expected death or anticipated withdrawal of life-sustaining therapies in next 24 hours
- •Pregnancy
- •Known allergy to midodrine
研究组 & 干预措施
Placebo
Microcrystalline cellulose PO/NG q8h
干预措施: Placebo (Drug)
Midodrine
Midodrine 10 mg PO/NG q8h
干预措施: Midodrine (Drug)
结局指标
主要结局
Hierarchical composite of 28-day mortality and ICU length of stay
时间窗: 1 year
The effects of midodrine on patient mortality at 28 days or total duration of patient stay in ICU
次要结局
- Mortality(1 year)
- Total and post-ICU length of stay(1 year)
- Duration of vasopressor support(1 year)
- ICU readmission(1 year)
- Re-initiation of vasopressors(1 year)
- Quality of life as measured by the EQ-5D-5L(1 year)
- ICU costs(1 year)
- Hospital costs(1 year)
- Total health care costs(1 year)
- Cost effectiveness(1 year)