一项针对心脏外科患者的氨基丁三醇(THAM)与碳酸氢钠对比研究
心脏外科患者中THAM与碳酸氢钠的比较:一项实用性、比较效果前瞻性试验
The purpose of this research is to determine if two commonly used medications to treat metabolic acidosis in the setting of cardiac surgery, sodium bicarbonate and THAM, are equivalent.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Nicole M. Lenort, RRT, LRT
- 电话号码:866-265-9263
- 邮箱:Lenort.Nicole@mayo.edu
学习地点
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Minnesota
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Rochester、Minnesota、美国、55901
- 招聘中
- Mayo Clinic
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接触:
- Nicole M. Lenort, RRT, LRT
- 电话号码:866-265-9263
-
首席研究员:
- Misty A. Radosevich, MD
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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
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Inclusion criteria
- Cardiothoracic surgery with use of cardiopulmonary bypass
- Presence of metabolic acidosis (defined as a base excess of <-5)
- Minnesota Research Authorization
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Exclusion criteria
- Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass
- Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of <-5)
- Pregnant patients
- Prisoners
- Opt out of Minnesota Research Authorization
学习计划
研究是如何设计的?
设计细节
- 主要用途: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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实验性的:Tris-hydroxymethyl aminomethane (THAM)
Patients randomized to the THAM arm will be treated with tris-hydroxymethyl aminomethane. Dosage: Base excess less than -5, administer 500 mL of THAM |
Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass, requiring treatment for metabolic acidosis (base excess less than -5), will receive tris-hydroxymethyl aminomethane (THAM) if randomized to the THAM arm.
其他名称:
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有源比较器:Sodium bicarbonate (Bicarb)
Patients randomized to the Bicarb arm will be treated with sodium bicarbonate (Bicarb). Dosage: Base excess less than -5, administer 100 mEq of sodium bicarbonate |
Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass and requiring treatment for metabolic acidosis (base excess less than -5), will receive sodium bicarbonate (Bicarb) if randomized to the Bicarb arm.
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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Change in pH following buffer administration
大体时间:Baseline, 2 hours
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pH will be measured via arterial blood gas test |
Baseline, 2 hours
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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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血管升压药物剂量变化
大体时间:基线,2小时
|
基线,2小时
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|
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正性肌力药物剂量变化
大体时间:基线,2小时
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基线,2小时
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Change in sodium
大体时间:Baseline, 2 hours
|
Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) |
Baseline, 2 hours
|
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Change in potassium
大体时间:Baseline, 2 hours
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Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) |
Baseline, 2 hours
|
|
Change in lactate
大体时间:Baseline, 2 hours
|
Lactate will be measured via blood test and reported in mmol/L (millimoles per liter) |
Baseline, 2 hours
|
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Change in (arterial partial pressure of carbon dioxide) PaCO2
大体时间:Baseline, 2 hours
|
PaCO2 will be measured via arterial blood gas test, reported as mmHg (millimeters of mercury) |
Baseline, 2 hours
|
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Change in cardiac index
大体时间:Baseline, 2 hours
|
Cardiac index is determined by dividing cardiac output by body surface area, with a normal range of 2.5-4.0 L/min/m² |
Baseline, 2 hours
|
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Change in Mean arterial pressure (MAP)
大体时间:Baseline, 2 hours
|
Mean arterial pressure (MAP) is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100, reported as mmHg (millimeters of mercury) |
Baseline, 2 hours
|
|
Duration of mechanical ventilation
大体时间:7 days
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Duration of mechanical ventilation will be reported in hours |
7 days
|
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Incidence of acute kidney injury
大体时间:7 days
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Number of patients who develop acute kidney injury |
7 days
|
|
Incidence of renal replacement therapy
大体时间:7 days
|
Number of patients who newly require renal replacement therapy |
7 days
|
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ICU length of stay
大体时间:7 days
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Number of days patient stays in ICU |
7 days
|
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Hospital length of stay
大体时间:7 days
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Number of days patient is hospitalized |
7 days
|
合作者和调查者
赞助
调查人员
- 首席研究员:Misty A. Radosevich, MD、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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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