Beyond muscle destruction: a systematic review of rhabdomyolysis for clinical practice.
Luis O Chavez, Monica Leon, Sharon Einav...
https://pubmed.ncbi.nlm.nih.gov/27301374Actively Recruiting
Led by Children's National Research Institute · Updated on 2025-07-03
50
Participants Needed
1
Research Sites
56 weeks
Total Duration
Researchers are studying the use of dexamethasone, a steroid, in addition to standard care for patients aged six months to 25 years diagnosed with rhabdomyolysis, a condition involving muscle breakdown. This study aims to evaluate whether adding dexamethasone improves pain, reduces hospital stay length, and lowers kidney complications. The trial is a blinded, randomized study conducted at a single center with up to 50 participants. Participants will be randomly assigned in a 2:1 ratio to receive either dexamethasone or a placebo once daily for five days, along with standard care. The dexamethasone dose is 0.6 mg/kg per day, up to a maximum of 16 mg. Both groups will follow the same treatment duration and schedules, with no additional interventions beyond the study medication and standard care. During the study, patients and their caregivers may complete surveys assessing pain before and after treatment. Researchers will review medical records throughout and after the five-day treatment period to monitor muscle breakdown, kidney issues, and length of hospital stay. The primary outcomes include measuring these factors from five days up to one year, with pain outcomes assessed up to 14 days. The trial involves careful monitoring and no extra procedures beyond standard care and study medication.
CONDITIONS
Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive either dexamethasone or placebo once daily for five days in addition to standard care.
Daily visits or assessments for 5 days
Duration - Up to 14 days after treatment
Participants and their caregivers may complete surveys before and after treatment to assess pain level and treatment improvement. Chart reviews will be performed throughout and after the treatment period.
1 to 2 visits depending on survey completion
Total: 1 location
1
Childrens National
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
N
Natasha Shur, MD
N
Natasha Shur, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Luis O Chavez, Monica Leon, Sharon Einav...
https://pubmed.ncbi.nlm.nih.gov/27301374Maxwell L Summerlin, Debra S Regier, Jamie L Fraser...
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https://pubmed.ncbi.nlm.nih.gov/32482689