酒精性肝病和 COVID-19 患者补充富含 HMB 的氨基酸的研究
评估富含 HMB 的氨基酸补充剂逆转酒精性肝病和 COVID-19 患者肌肉损失的分子机制
Patients with COVID-19 and comorbidities including alcohol associated liver disease (ALD) are at risk for severe illness and abrupt or sudden clinical deterioration with ventilatory failure. â-hydroxy â-methyl butyrate (HMB), a non-nitrogenous leucine metabolite with anabolic properties, increases muscle mass and contractile function and enhances immune function. We aim to study the natural course of COVID-19 in patients with ALD and test whether HMB can affect ventilatory deterioration and improve short and long-term morbidity, mortality, and recovery from critical illness in symptomatic COVID-19 patients with ALD.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alina Tuladhar, MPH
- 电话号码：216-445-6268
- 邮箱：tuladha@ccf.org
研究联系人备份
- 姓名：Annette Bellar, MSLA
- 电话号码：216-445-0688
- 邮箱：bellara@ccf.org
学习地点
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Ohio
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Cleveland、Ohio、美国、44195
- 招聘中
- Cleveland Clinic Foundation
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接触：
- Alina Tuladhar, MPH
- 电话号码：216-445-6268
- 邮箱：tuladha@ccf.org
-
首席研究员：
- Srinivasan Dasarathy, MD
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接触：
- Annette Bellar, MSLA
- 电话号码：216-445-0688
- 邮箱：bellara@ccf.org
-
-
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:
A. Cases: Patients with ALD and COVID-19 pneumonia:
- Clinical, imaging, laboratory, and/or histological diagnosis of alcoholic cirrhosis and/or alcoholic hepatitis
- Child Pugh score 5-8, serum creatinine <3, Model for End Stage Liver Disease score (MELD) <25
- Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 <93% or on oxygen supplement
- Age of 21 years or older
B. Controls: Patients without alcoholic liver disease (Non-ALD) and COVID-19 pneumonia:
- Diagnosis of COVID-19 pneumonia as defined by the WHO criteria: confirmed SARS-CoV-2 infection by PCR, evidence of bilateral pulmonary infiltrates on chest radiograph (CXR) or computed tomography (CT) and SpO2 <93% or on oxygen supplement
- Age of 21 years or older
Exclusion Criteria: (Both Cases and Controls)
- Patients requiring active ventilator support
- Anticoagulant/antiplatelet therapy (for those in the biopsy arm, see Randomization schema. If clinically feasible, patients will be asked to hold their anticoagulants for the muscle biopsy after physician review),
- Recent gastrointestinal bleeding (<3 months)
- Advanced organ diseases: congestive heart failure (NYHA class 3 and 4), chronic obstructive pulmonary diseases (COPD) (GOLD stage 3 and 4), chronic kidney disease (Cr>3), metastatic malignancy
- Medications that alter muscle protein metabolism except systemic corticosteroids
- Pregnancy
- Unwillingness/ Inability to sign informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：HMB enriched amino acid arm
The patients randomized to the HMB enriched amino acid (HMB/EAA) arm will be given HMB/EAA for 90 days. |
β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties. |
|
安慰剂比较：Balanced amino acid arm
The patients randomized to the Balanced amino acid (BAA) arm will be given BAA for 90 days. |
Balanced amino acid is the balanced mixture of the various essential amino acids. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
第 0 天和第 90 天骨骼肌质量的变化
大体时间：基线和第 90 天
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基线和第 90 天
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第 0 天和第 90 天之间的住院人数
大体时间：基线和第 90 天
|
基线和第 90 天
|
合作者和调查者
调查人员
- 首席研究员：Srinivasan Dasarathy, MD、Staff
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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