Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
研究概览
简要总结
This is a prospective cohort study for 50 patients admitted to the cardiac care unit requiring clinically-indicated diuretic therapy for congestive heart failure. The purpose of this study is to assess the role of non-invasive cardiac output monitoring (NICOM) with the Starling Fluid Management System (Baxter Medical, Deerfield, IL) in determining volume status in patients with acute decompensated heart failure requiring intravenous diuretic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis
- •Admission to coronary/cardiac intensive care unit or cardiac step down unit
- •Able to provide written informed consent
- •Anticipated need for IV diuretics > 24 hrs
排除标准
- •Prisoner, pregnancy or post-partum stage, or age < 18 years
- •Known allergy to sensory material or gel
- •End stage renal disease or need for CRRT
- •Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)
- •Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator
- •Inability to provide informed consent
结局指标
主要结局
Percent Change in Stroke Volume Index (SVI) after passive leg raise (PLR)
时间窗: Baseline, At Discharge (up to 1 week)
The Startling System non-invasive cardiac output monitoring (NICOM) device will use a proprietary algorithm to determine SVI. A passive leg raise (PLR) is then performed to increase preload and then the Starling System takes a second set of measurements to determine the parameters above as well as the change in stroke volume index.
次要结局
- Change in heart rate after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Output (CO) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Output (CO) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Stroke Volume Index (SVI) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Index (CI) before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in estimated Cardiac Index (CI) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in heart rate before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Mean arterial pressure before passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Mean arterial pressure after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))
- Change in Stroke Volume Index (SVI) after passive leg raise (PLR)(Baseline, At Discharge (up to 1 week))