Evaluating Muscle Weakness Improvement With Lorcaserin in ICU
Status: | Enrolling by invitation |
---|---|
Conditions: | Hospital, Neurology |
Therapuetic Areas: | Neurology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/19/2018 |
Start Date: | December 2015 |
End Date: | December 2019 |
Evaluating Lorcaserin Drug Therapy For ICU-Acquired Weakness: A Pilot Randomized Trial
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.
illness. This trial will evaluate the safety and efficacy of a drug in improving muscle
weakness in critically ill patients.
Inclusion Criteria:
1. Age ≥18 years old
2. Sepsis [ ≥2 Systemic Inflammatory Response Syndrome (SIRS) Criteria AND known or
suspected infection]
3. Muscle weakness [Medical Research Council sum score <48/60 or handgrip strength <11 kg
in men and <7 kg in women]
4. Obey Commands [Score for DeJonghe Awakening Score of ≥3/5]
Exclusion Criteria:
1. Severe renal insufficiency [Creatinine Clearance <30 mL/min - or receiving dialysis]
2. Acute infectious or auto-immune hepatitis, acute liver failure or a history of
cirrhosis without liver transplant
3. History of psychosis
4. Bradycardia, or 2nd or 3rd degree AV block without pacemaker
5. History of valvular heart disease without valve replacement
6. History of priapism
7. Pre-existing cognitive impairment
8. Receiving drugs with serotonergic effects and/or CYP2D6 substrates which cannot be
substituted stopped or titrated.
9. Receiving Sulfonylurea medication at the time of the study
10. Prior neuromuscular or central nervous system disease, including pre-existing
neuropathy
11. Inability to perform study's muscle strength assessments based on patient's baseline
status prior to hospital admission
12. Unable to receive, or unlikely to absorb study drug (e.g. bowel obstruction, ischemia,
or infarction; short gut syndrome)
13. Body mass index >40
14. Patient not expected to survive >4 days
15. Pregnancy or lactation
16. Allergy to lorcaserin or lorcaserin taken in the prior 7 days
17. Enrolled in another interventional drug or physical rehabilitation trial
18. Physician declines for patient to be enrolled
19. Patient or proxy declines consent
20. Unable to reach proxy for consent
21. Non-English speaking
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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