Evaluating Muscle Weakness Improvement With Lorcaserin in ICU

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University

Criteria

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