NCT02822170已完成不适用
A Pilot Study of Combined Cycle Ergometry and Amino Acids in the ICU
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 6-minute walk distance (6MWD)
研究概览
简要总结
The purpose of this small pilot study is to refine a combined intervention of IV amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center RCT. A total of 10 patients will receive the combined intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •>=18 years old
- •Requiring mechanical ventilation or high flow nasal cannula (HFNC) with actual or expected total duration of mechanical ventilation or HFNC >48 hours
- •Expected ICU stay >4 days after enrollment (to permit adequate exposure to the proposed intervention)
排除标准
- •>120 continuous hours of mechanical ventilation or HFNC before enrollment
- •Expected death or withdrawal of life-sustaining treatments within 7 days from enrollment
- •No expectation for any nutritional intake within the subsequent 72 hours
- •Severe chronic liver disease (MELD score >20) or acute fulminant hepatitis.
- •Documented allergy to the amino acid intervention
- •Not ambulating independently prior to ICU admission (use of gait aid permitted)
- •Pre-existing primary systemic neuromuscular disease (e.g. Guillain Barre)
- •Neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met)
- •Pre-existing intracranial or spinal process affecting motor function
- •Pre-existing cognitive impairment or language barrier that prohibits outcomes assessment
- •Lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury)
- •Weight >150kg
- •Incarcerated
研究组 & 干预措施
IV amino acids and in-bed cycle ergometry
Experimental
Beginning within 96 hours of ICU admission, participants will receive the following combined intervention:
- IV amino acids (15% solution) delivered by continuous infusion, such that the total enteral and IV protein will be between 2.0-2.5 g/kg/day.
- In-bed cycle ergometry exercise delivered in 45-minute sessions 5 days per week according to a detailed specific protocol that includes a safety check and gradual increases in resistance if the participant is actively cycling.
干预措施: IV amino acids and in-bed cycle ergometry (Other)
结局指标
主要结局
6-minute walk distance (6MWD)
时间窗: 6MWD will be measured near the time that the particioant is being discharged from the hospital, up to 26 weeks after randomization.
次要结局
未报告次要终点
研究者
Renee Stapleton
Associate Professor of Medicine
University of Vermont
研究点 (1)
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