Adding dexamethasone to standard care for children and young adults with rhabdomyolysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind Phase 1 trial enrolling up to 50 patients aged 6 months to 25 years with rhabdomyolysis (CK >5000) not due to trauma. Participants are randomized 2:1 to receive oral dexamethasone or placebo once daily for five days in addition to standard care. Pain surveys and chart reviews will be used to track symptoms, length of stay, and kidney-related outcomes during and after the five-day treatment period. The study is planned to run two years at a single pediatric center.

Why it matters

Who can join: the full rules

Inclusion Criteria

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

Exclusion Criteria:

* 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's running

• Childrens National
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Natasha Shur, MD — Children's National Research Institute
• Study coordinator: Natasha Shur, MD
• Email: nshur2@childrensnational.org
• Phone: 202-476-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.