Strength Testing After Nitrate Delivery (STAND) in ICU Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- physical function assessed using the Short Physical Performance Battery (SPPB)
研究概览
简要总结
It is well documented that intensive care unit (ICU) patients have lower levels of skeletal muscle strength compared to non-ICU patients upon hospital discharge, and this weakness affects the patient's ability to perform basic activities of daily living upon hospital discharge and for extended periods thereafter. Recently, critically ill ICU patients have been shown to have lower nitric oxide levels. These patients often suffer from a disturbed homeostasis with circulatory and metabolic abnormalities that may potentially contribute to their ICU acquired weakness. Given the recent research showing dietary nitrate supplementation can increase nitric oxide levels and improve exercise tolerance in healthy and diseased older individuals, our aim is to investigate the importance of nitrate supplementation in ICU patients with focus on physical function and ICU acquired muscle weakness.
详细描述
The proposed study is an investigator initiated, double blind, placebo controlled experimental study designed to evaluate the effect of chronic NO3- supplementation via beetroot juice ingestion on the skeletal muscle strength and physical function in ICU patients. Patients will be randomized to receive either nitrate rich or nitrate depleted beetroot juice once daily during their ICU and hospital stay. Physical function and skeletal muscle strength will be measured at ICU (± 2 days) and hospital (± 2 days) discharge and 2 months (± 2 weeks) after enrollment. Plasma levels of nitrate and nitrite will be measured 1, 3 and 5 days after randomization into the trial and at ICU and hospital discharge. Skeletal muscle ultrasound will be performed to examine the size and echogenicity of patient muscles. Self-reported physical function will be measured using the Functional Performance Inventory Short Form (FPI-SF). The FPI-SF provides an overall score of patient self-reported functional performance in the areas of household maintenance, movement, family and social activities, work, avocation and recreation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 55 years
- •Mechanically ventilated via an endotracheal tube or mask who have begun spontaneous breathing trials or extubated within the previous 24 hours
- •Lung Injury as defined by a PaO2 / FiO2 < 300
排除标准
- •Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
- •Cognitive impairment prior to acute ICU illness (non-verbal)
- •Acute stroke
- •Body mass index (BMI) >50
- •Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
- •Hip fracture, unstable cervical spine or pathological fracture
- •Mechanically Ventilated > 80 hours
- •Current hospitalization or transferring hospital stay > 7 days
- •DNR/DNI on admission
- •Cancer treatment within the last 6 months
- •Participation in another research study
- •On nitroglycerine or nitrate preparations used with angina or phosphodiesterase type 5 inhibitors
- •Body mass less than 60 kg
研究组 & 干预措施
Nitrate Rich
A nitrate rich beetroot juice supplement (Beet It Shot®, James White Drinks, UK) high in nitrates will be provided to the subjects. Subject's diet will be supplemented once daily while hospitalized up to 14 days with one 70 ml bottle containing 300 mg of dietary nitrate.
干预措施: Nitrate Rich Beetroot Juice (Dietary Supplement)
Nitrate Depleted
This group will consume a beetroot juice supplement (Beet It Shot®, James White Drinks, UK) that has had the nitrate removed from the beverage by the manufacturer. Patient's diet will be supplemented once daily with one 70 ml bottle while hospitalized up to 14 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
physical function assessed using the Short Physical Performance Battery (SPPB)
时间窗: 2 months
The SPPB is based on timed measures of standing balance, walking speed, and ability to rise from a chair. Each performance measure is assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 inability to complete the test. A summary score (range 0-12) will be calculated by adding the three scores.
次要结局
- Plasma Nitrate and Nitrite Levels(5 days)
- Skeletal muscle strength(2 months)
- Hospital Length of Stay(2 weeks)