Actively Recruiting

Phase 1
Age: 6Months - 25Years
All Genders
NCT06429982

Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Led by Children's National Research Institute · Updated on 2025-07-03

50

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Who Can Participate

Age: 6Months - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of rhabdomyolysis with creatine kinase over 5000 and trauma excluded
  • Ability of parents or patients to understand and willingness to sign written informed consent
  • Patients aged 12 years and older must sign written assent
Not Eligible

You will not qualify if you...

  • Currently taking systemic steroids
  • Inability to comply with study instructions
  • Uncontrolled illness or psychiatric/social conditions limiting compliance
  • Pregnant women (urine pregnancy test required if applicable)
  • Gestational age below 40 weeks
  • Allergy to fluconazole, clotrimazole, or nystatin
  • Unable to tolerate oral medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Childrens National

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

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Research Team

N

Natasha Shur, MD

CONTACT

N

Natasha Shur, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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