Actively Recruiting

Phase 1
Age: 6Months - 25Years
All Genders
ID06429982

Dexamethasone Addition to Standard Protocols for Non-Traumatic Rhabdomyolysis in Patients Aged 6 Months to 25 Years: A Randomized Clinical Trial

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

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief 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 greater than 5000 and no trauma
  • Ability of parents or patients to understand and willingness to sign informed consent
  • Patients aged 12 and older must sign written assent
Not Eligible

You will not qualify if you...

  • Currently taking systemic steroids
  • Unable to comply with study instructions
  • Uncontrolled illness or psychiatric/social issues limiting compliance
  • Pregnant women (urine pregnancy test for women of child-bearing potential)
  • Gestational age below 40 weeks
  • Allergy to fluconazole, clotrimazole, or nystatin
  • Unable to tolerate oral medications

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Childrens National

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

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Research Team

N

Natasha Shur, MD

N

Natasha Shur, MD

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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