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临床试验/NCT03222778
NCT03222778已完成不适用

Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Predictive ability of combined echocardiographic index consisting of LVEDA, e, e', s' or a'

研究概览

简要总结

In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid resuscitation guided by reliable preload indices is of pivotal importance as only half of them are fluid responsive, and that empiric fluid administration actually leads to dismal prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'), and LV stiffness (e'/a'). Although the left ventricular end-diastolic area (LVEDA) alone is not a valid predictor of fluid responsiveness, combining LVEDA with these indices would provide comprehensive information regarding the LV dimension, preload, and compliance as well as systolic function. Also, it seems logical to assume that patients with low LVEDA and high e' velocity indicating preserved early diastolic relaxation or low e (early mitral inflow velocity) /e' ratio indicating normal LV filling pressure would more likely be fluid responsive. Yet, these assumptions have not been tested before. Moreover, these values can be reliably obtained regardless of the heart rhythm, except for a', and do not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the aim of this prospective trial is to investigate the role of LVEDA combined with e, e', a' or s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump coronary bypass surgery, in closed-chest conditions.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the patients scheduled for off-pump coronary bypass surgery
  • tha age ≥20 yrs old
  • the patients who are willing to provide written informed consent

排除标准

  • heart rhythm other than sinus, L, septal and/or lateral wall motion abnormalities, and a
  • New York Heart Association functional class ≥III
  • LV ejection fraction <40%
  • emergency operation
  • the patients with preoperative septal and/or lateral wall motion abnormalities
  • contraindications to transesophageal echocardiography or balanced 6% hydroxyethyl starch 130/0.4
  • the patients with any valvular heart disease ≥moderate degree
  • No communication possible due to a language barrier or deafness

结局指标

主要结局

Predictive ability of combined echocardiographic index consisting of LVEDA, e, e', s' or a'

时间窗: 15 to 20 min after anesthetic induction during closed chest condition

Fluid challenge is performed once using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4 (Volulyte; Fresenius Kabi, Bad Homburg, Germany) 15 to 20 min after anesthetic induction during closed chest condition. Fluid responsiveness is defined as an increase in stroke volume index of ≥ 15%. Assessment of echocardiographic variables \[LVEDA, e, e', a' or s'\] is performed before fluid challenge. We assess the predictive ability of a combined echocardiographic preload index consisting of LVEDA, e, e', s' or a' on fluid responsiveness using the area under the Receiver Operating Characteristic (ROC) curve (AUROC).

次要结局

  • Comparison between the combine echocardiographic index and LVEDA alone, CVP, PCWP, RVEDV and PPV for the predictive ability on fluid responsiveness(15 to 20 min after anesthetic induction during closed chest condition)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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