Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Rhabdomyolysis

In brief

There is a significant unmet need for optimized treatment in rhabdomyolysis. There are few prospective interventional studies on treatment for rhabdomyolysis, a condition which affects diverse and underrepresented populations at a higher rate. While steroids are often used off-label, a systematic study has not yet been initiated, and steroids have not been yet considered in as a consideration to standard care guidelines. The hypothesis is that patients who receive dexamethasone in addition to standard care versus placebo and standard care will have improvement in pain, length of hospital stay, and decrease in kidney complications.

Key facts

Study ID: NCT06429982
Run by: Children's National Research Institute
People needed: 50
Starts: 2024-10-01
Expected to finish: 2026-12-31
Last updated by the study team: 2025-07-03

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of rhabdomyolysis defined as creatine kinase> 5000 with trauma excluded
Ability of parents/patients to understand and the willingness to sign a written informed consent document.
Patients ages 12 and older will sign written assent

You may not qualify if…

Already taking systemic steroids.
Inability to comply with study instructions.
Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women.
o A urine pregnancy test will be performed for women of child-bearing potential.
Below gestational age of 40 weeks
Allergy to fluconazole, clotrimazole or nystatin.
Cannot tolerate PO medications

Where it is running

Childrens National — Washington D.C., District of Columbia, United States (enrolling)

Full record on ClinicalTrials.gov

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