Assessment of the Effectiveness and Safety of Dynamic Arterial Elastance in Weaning Vasopressor Support in Patients with Septic Shock: a Randomized Controlled Clinical Trial At Santa Fé Foundation in Bogotá
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Duration of vasopressor support
研究概览
简要总结
Assess the effectiveness and safety of using dynamic arterial elastance as a tool for weaning vasopressor support in patients with septic shock, compared to a control group
详细描述
An open-label, randomized controlled clinical trial will be conducted with two patient groups. Our hypothesis is that using dynamic arterial elastance (EaDyn) as a tool to guide vasopressor weaning can reduce the duration of vasopressor support. Eligible patients will be randomly assigned to either the EaDyn weaning arm or the mean arterial pressure (MAP) weaning arm in a 1:1 ratio. Blinding of participants and investigators will not be possible due to the study's methodology. The analysis will be conducted on an intention-to-treat basis.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age.
- •Admission to the ICU.
- •Septic shock defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
- •Hypotension requiring vasopressor support to maintain a MAP ≥ 65 mmHg.
- •SOFA score ≥
- •Vasopressor support duration ≥ 4 hours.
- •Patients requiring mechanical ventilation.
- •Patients who have reached the hemodynamic stabilization phase and are ready to begin the vasopressor weaning process with norepinephrine, defined as: mean arterial pressure (MAP) > 75 mmHg, cardiac index (CI) > 2.5 L/min/m², and lactate level < 2 mmol/L.
排除标准
- •Pregnant individuals.
- •Hemodynamic instability due to cardiac arrhythmias.
- •Hepatic cirrhosis.
- •Kidney or liver transplant.
- •High probability of mortality within 24 hours, according to medical judgment.
- •Left ventricular ejection fraction (LVEF) less than 50%.
- •Right ventricular dysfunction, defined as a TAPSE (Tricuspid Annular Plane Systolic Excursion) measurement of less than 1.6 cm.
- •Patients spontaneously breathing.
结局指标
主要结局
Duration of vasopressor support
时间窗: 30 days
Defined as the time interval in hours from the initiation of vasopressor support to its discontinuation.
次要结局
- Cumulative vasopressor dosage.(30 days)
- Overall hospital length of stay in days(90 days)
- Overall ICU length of stay in days.(90 days.)
- Acute Kidney Injury (AKI).(90 days.)
- Mortality(90 days.)
研究者
Jorge Iván Alvarado
Anesthesiologist
Fundación Santa Fe de Bogota