NCT05036122撤回不适用
Validation of a Non-Invasive Instrument to Estimate Blood Lactate
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood [lactate] during incremental exercise
研究概览
简要总结
The purpose of this study is to validate the LabClasp's ability to estimate blood [lactate].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to provide written consent.
- •Adults 18 years of age and older.
- •Nonsmokers.
- •No recent hospitalization (< 60 days).
- •Ability to perform high-intensity exercise.
- •Inclusion Criteria - Aim 2:
- •Subjects must be able to provide written consent to be included in the research study.
- •Adults 18 years of age and older.
- •Nonsmokers.
- •Current ICU patient.
- •Have regular blood samples taken for [lactate] measurements.
- •Have one or more risk factors for sepsis.
排除标准
- •Aims 1 and 2:
- •History of, or active malignancy.
- •History of HIV with antiretroviral treatment.
- •Pregnancy.
研究组 & 干预措施
Whole-body exercise in healthy adults (Aim 1)
Experimental
Subjects will have blood [lactate] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle.
干预措施: LabClasp (Device)
ICU patients susceptible to developing sepsis (Aim 2)
Experimental
Subjects will have blood [lactate] measurement obtained with the LabClasp device as frequently as required for clinical purposes
干预措施: LabClasp (Device)
结局指标
主要结局
Blood [lactate] during incremental exercise
时间窗: 1 day
Measured via venous blood and the LabClasp
Blood [lactate] measurements in ICU patients
时间窗: 1 day
Measured via venous blood and the LabClasp
次要结局
未报告次要终点
研究者
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic
研究点 (1)
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