Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

Phase 1

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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]

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Intervention	Lorcaserin	Lorcaserin will be administered as a single dose on day 1 and day 3 to participants in this arm.
Control	Placebo	Placebo will be administered as a single dose on day 1 and day 3 to participants in this arm.

Primary Outcome Measures

Name	Time	Method
Change in Handgrip Strength as Measured by Hand Dynamometer	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)

Secondary Outcome Measures

Name	Time	Method
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	Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 \[no visible or noticeable contraction\] to 5 \[maximum strength\] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).
Change in Handgrip Strength as Measured by Hand Dynamometer	Baseline and 2 to 6 hours after administration of 10mg 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)
Change in Quadriceps Strength as Measured by Handheld Dynamometer	Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo	Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.