Evaluation of the E/e' Ratio of the Mitral Annulus Measured by Transesophageal Echocardiography in Predicting Fluid Responsiveness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mitral valve E/e' ratio for prediction of fluid responsiveness
研究概览
简要总结
Diastolic function may be evaluated by different measurements on transesophageal echocardiography (TEE). They include mitral inflow velocities obtained by pulsed-wave doppler (PW) : peak early diastolic velocity (E) and late diastolic velocity (A). Mitral annulus velocities, early diastolic (e') and late diastolic (a') are obtained by tissue doppler imaging (TDI). The ratio E/e' reflects left ventricular filling pressure and, as such, might be a predictor of fluid responsiveness.
The aim of this study is to evaluate the predictive value of the mitral valve E/e' ratio for fluid responsiveness among patients undergoing coronary bypass graft surgery. Fluid responsiveness being defined as an increase in stroke volume of ≥ 15%.
After induction of anesthesia, patients will have their diastolic function evaluated by means of E/e' and other measures. They will then be administered an intravenous bolus of 500 mL of Lactate Ringer® along with passive leg raising (PLR). Stroke volume and fluid responsiveness will be assessed by the thermodilution method (Swan-Ganz catheter) and the FloTrac® device. Fluid responders will be compared to non-responders to evaluate the relationship between E/e' ratio and fluid responsiveness.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 其他
- 盲法
- 开放（无盲法）
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 >18 yrs, undergoing elective coronary artery bypass grafting or surgery will be included.
排除标准
- Significant mitral valvular heart disease (mitral regurgitation ≥ 2/4 or stenosis)
- Significant right sided valvular heart disease (tricuspid regurgitation ≥ 2/4)
- Intracardiac shunts
- Emergency surgery
- Non-sinusal rythme
- Clinical evidence of decompensated heart failure
- Clinical evidence of decompensated pulmonary hypertension
- Renal insufficiency with creatinine clairance ≤ 30 cc/min or dialysis
- Contraindications to TEE, including esophageal disease or unstable cervical spine
- CVP ≥ 15 mm Hg or PCWP ≥ 18 mm Hg immediately before fluid infusion
结局指标
主要结局
Mitral valve E/e' ratio for prediction of fluid responsiveness
时间窗: TEE images taken within the 15 minutes before fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising
TEE evaluation of mitral inflow velocities and mitral annulus velocities measured right before fluid administration as a predictor of fluid responsiveness defined as an increase of 15% or more of the stroke volume
次要结局
- Pulse pressure variation (PPV) for prediction of fluid responsiveness(PPV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising)
- Stroke volume variation (SVV) for prediction of fluid responsiveness(SVV measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising)
- Pulmonary capillary wedge pressure (PCWP) a-wave to v-wave ratio of the for prediction of fluid responsiveness(Waveform measured within the 15 minutes preceding fluid administration and responsiveness evaluation within the 5 minutes following fluid administration and leg raising)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT02714244
- 其他研究编号
- 2014-1671
日期
- 首次提交
- (10年前)
- 首次发布
- (10年前)
- 主要完成日期
- (9年前)
- 研究完成日期
- (9年前)
- 最近核实
- (9年前)
- 最近更新
- (9年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否