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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
Oral or enteral, single dose. Oral or enteral, single dose two days later
Johns Hopkins University
Baltimore, Maryland, United States
Change in Handgrip Strength as Measured by Hand Dynamometer
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)
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Handgrip Strength as Measured by Hand Dynamometer
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)
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
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).
Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score
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).
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
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Time frame: Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo
Change in Quadriceps Strength as Measured by Handheld Dynamometer
Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.
Time frame: Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo