NCT02523690终止1 期
Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Handgrip Strength as Measured by Hand Dynamometer
研究概览
简要总结
ICU acquired muscle weakness is a significant problem in patients recovering from critical illness. This trial will evaluate the safety and efficacy of a drug in improving muscle weakness in critically ill patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥18 years old
- •Sepsis [ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or suspected infection]
- •Muscle weakness [Medical Research Council sum score <48/60 or handgrip strength <11 kg in men and <7 kg in women]
- •Obey Commands [Score for DeJonghe Awakening Score of ≥3/5]
排除标准
- •Severe renal insufficiency [Creatinine Clearance <30 mL/min - or receiving dialysis]
- •Acute infectious or auto-immune hepatitis, acute liver failure or a history of cirrhosis without liver transplant
- •History of psychosis
- •Bradycardia, or 2nd or 3rd degree Atrio-Ventricular block without pacemaker
- •History of valvular heart disease without valve replacement
- •History of priapism
- •Pre-existing cognitive impairment
- •Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be substituted stopped or titrated.
- •Receiving Sulfonylurea medication at the time of the study
- •Prior neuromuscular or central nervous system disease, including pre-existing neuropathy
- •Inability to perform study's muscle strength assessments based on patient's baseline status prior to hospital admission
- •Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia, or infarction; short gut syndrome)
- •Body mass index >40
- •Patient not expected to survive >4 days
- •Pregnancy or lactation
- •Allergy to lorcaserin or lorcaserin taken in the prior 7 days
- •Enrolled in another interventional drug or physical rehabilitation trial
- •Physician declines for patient to be enrolled
- •Patient or proxy declines consent
- •Unable to reach proxy for consent
- •Non-English speaking
研究组 & 干预措施
Intervention
Experimental
Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
干预措施: Lorcaserin (Drug)
Control
Placebo Comparator
Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Handgrip Strength as Measured by Hand Dynamometer
时间窗: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)
次要结局
- Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score(Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo)
- Change in Handgrip Strength as Measured by Hand Dynamometer(Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo)
- Change in Quadriceps Strength as Measured by Handheld Dynamometer(Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo)
研究者
研究点 (1)
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