Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair
Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial
Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.
Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.
Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.
研究概览
地位
条件
详细说明
Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.
Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Arkhangelsk、俄罗斯联邦、163000
- City hospital # 1 / Northern State Medical University,
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Two valve repair / replacements
- Age above 18
- Informed consent
Exclusion Criteria:
- pulmonary hypertension
- insulin-dependent diabetes mellitus
- severe atherosclerosis of femoral arteries
- severe respiratory failure
- pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Pulmonary artery catheter (PAC)
PAC was used to guide hemodynamic therapy after combined valve repair
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the data s=derived from PAC included pulmonary artery occlusion pressure etc
其他名称:
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有源比较器:COMPLEX
An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery.
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Described in details above
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mortality
大体时间:Day 28
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Mortality rate at Day 28
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Day 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Fit for discharge
大体时间:non actual
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Formal 'fit for discharge from ICU' criteria
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non actual
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Vasoactive support
大体时间:7 days
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Duration of vasopressor and or inotrope support
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7 days
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Duration of respiratory support
大体时间:Day 7
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The total duration of the respiratory support
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Day 7
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合作者和调查者
调查人员
- 首席研究员:Mikhail Y. Kirov, MD, PhD、Northern State Medical University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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