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

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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.


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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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from
Baltimore, MD
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