Pilot Study- Permissive Hypotension After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- MAP in mmHg
研究概览
简要总结
The objective of this pilot randomized controlled trial is to demonstrate the feasibility of implementing a pragmatic clinical trial randomizing patients to permissive hypotension versus usual care and to determine the impact of permissive hypotension on vasopressor exposure, ICU length of stay, markers of end organ perfusion, and clinically relevant patient outcomes. The data collected from this pilot study will be used as preliminary data for study design and grant applications for a larger multicenter randomized controlled trial.
详细描述
The investigators will perform a single center, open-label, randomized controlled trial in patients admitted to the HCICU after cardiac surgery at MGH. Patients who are hypotensive (MAP < 65mmHg) and/or require vasopressor support to maintain a MAP ≥ 65mmHg during the first 24 hours of ICU admission will be eligible for randomization. Patients will be randomized in 1:1 fashion to either a) Permissive Hypotension (MAP target >60mmHg) or b) Usual Care. The duration of the intervention will extend until the patient no longer needs vasopressors to maintain prespecified MAP. Outcomes of interest include continuous hemodynamics (both recorded values from EHR as well as the arterial line waveform data), vasopressor exposure (as measured by maximum Vasopressor-Inotrope Score, mean Vasopressor-Inotrope Score, and duration of vasopressor use), lactate clearance, rates of atrial fibrillation, need for renal replacement therapy, ICU length of stay, survival to hospital discharge, cognitive state at discharge using Montreal Cognitive Assessment score. Additionally, the investigators will perform exploratory analyses using the continuous arterial line waveform data to evaluate for potential differences in arterial waveform morphologies between groups to help discern the hemodynamic impacts of permissive hypotension and to potentially identify subphenotypes who may derive greater benefit.
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
- None
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
- •18 years or older
- •Schedules for elective or non-emergent cardiac surgery
排除标准
- •Arrival to the CICU with severe shock determined any of the following: Norepinephrine dose >20mcg/min, Epinephrine >3mcg/min, Dobutamine >2.5mcg/kg/min, Milrinone >0.2mcg/kg/min
- •Rapidly increasing pressors within 60 mins of arrival.
- •Significant prior renal dysfunction (CKD >4), hemodialysis dependence
- •Cirrhosis
- •A neuropathology diagnosis warranting blood pressure goal
- •Pre-specified MAP goal as determined by clinical team
- •Carotid stenosis (> 50%) or prior stroke
- •Bleeding requiring return to the OR
- •Need for mechanical circulatory support
- •Heart and Lung transplantation
- •Aortic dissection
研究组 & 干预措施
Standard of Care
Patients randomized to the standard of care arm will receive the regular care provided to cardiac surgery patients.
Permissive hypotension Intervention
In addition to the regular care provided to cardiac surgery patients, those in the permissive hypotension intervention arm will have a MAP target > 60mmHg.
干预措施: Permissive Hypotension (Other)
结局指标
主要结局
MAP in mmHg
时间窗: Through study completion, an average of 2 to 3 days
(Mean arterial pressure) measured in millimetres of mercury
Vasoactive-Inotropic Score for duration of pressor need
时间窗: Through study completion, an average of 2 to 3 days
Weighted sum of all administered vasopressor and inotropic medications and quantifies the amount of pharmacological support in patients
次要结局
- Duration of end organ support(Through study completion, an average of 2 to 3 days)
- Cognitive function assessed using Montreal Cognitive Assessment (MOCA)(Through study completion, an average of a week)
- Mortality(Through study completion, an average of a week)
- Tissue perfusion pressure via continuous arterial waveform monitoring(Through study completion, an average of 2 to 3 days)
- ICU and hospital length of stay(Through study completion, an average of a week)
- Duration of inotrope and vasopressor exposure(Through study completion, an average of 2 to 3 days)
研究者
Asishana A Osho
Assistant Professor of Surgery
Massachusetts General Hospital