Clinical Observation of Mean Systemic Filling Pressure in Critical Care Patients With Continuous Diuretics Administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in mean systemic filling pressure (mmHg)
研究概览
简要总结
Within clinical settings observation of hemodynamic changes (e.g. mean systemic filling pressure, cardiac output) in critically ill patients with a clinical indication for deresuscitation with intravenous diuretic therapy.
详细描述
Rationale: The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need for adequate determination of intravascular volume status. However, in determining the intravascular fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment.
Positive fluid balance and /or substantial weight gain in critically ill patients is a common problem in the intensive care unit (ICU), potentially associated with a poor outcome. This problem, in association with hemodynamic instability and increase of creatinin, ureum and sodium, may lead to peripheral edema. Furosemide, a loop diuretic, is frequently administered to critically ill patients to increase urine output and to relieve edema.
Objective: Observing changes in Pms during continuous furosemide administration.
Study design: Prospective, observational study Study population: Patients with a PICCO® system with a positive fluid balance and / or substantial weight gain and therefore with a clinical indication for diuretic therapy.
Intervention: Continuous furosemide administration. Main study parameters/endpoints: Pms measured at baseline, changes in Pms during continuous furosemide administration.
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
- •Patients must be at least 18 years
- •PiCCO in situ (cardiac output device applied in light of clinical treatment)
- •CVL in situ
- •Clinical indication for continuous furosemide administration
排除标准
- •Patients younger then 18 years
- •Patients without PiCCO
- •Pregnant women
结局指标
主要结局
Change in mean systemic filling pressure (mmHg)
时间窗: Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours
Decrease or increase in mean systemic filling pressure measured by bedside continuous hemodynamic monitor supplied with continuous cardiac output monitoring with PiCCO(R) device
次要结局
- Change in cardiac index (L/min/m2)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in mean arterial pressure (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in central venous pressure (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in pressure for venous return (mmHg)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in extra vascular lung water index (mL/kg)(Baseline and after 24 hours)
- Change in intrathoracic blood volume index (mL/m2)(Baseline and after 24 hours)
- Creatinin (renal function) mmol/L(Baseline and after 24 hours)
- Change in resistance to venous return (dynes⋅sec⋅cm-5)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in systemic vascular resistance index (dynes⋅sec⋅cm-5)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in heart rate (bpm)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in venous return index (L/min/m2)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
- Change in global end diastolic volume index (mL/m2)(Baseline and after 24 hours)
- Diuresis per hour (mL/hour)(Baseline, 1 hour, 2 hours and after 24 hours)
- Body weight (kg)(Baseline and after 24 hours)
- Fluid balance (mL)(Baseline and after 24 hours)
- Electrolyte balance (potassium, sodium levels) (mmol/L)(Baseline and after 24 hours)
- Change in cardiac performance (eH) (dimensionless)(Baseline, every 5 minutes up to 30 minutes, 1 hour, 2 hours)
研究者
L.P.B. Meijs
Principal investigator L.P.B. Meijs, MD, PhD-candidate Intensive Care Unit / resident cardiology
Catharina Ziekenhuis Eindhoven