Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
Recruiting
Phase 1Interventional Study
Rhabdomyolysis
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At a Glance
Age
6 Months – 25
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Children's National Research Institute · Other
Who this trial is looking for
This trial is looking for children and teenagers with rhabdomyolysis. Participants will receive dexamethasone along with standard treatments to see if it helps improve their pain and hospital stay.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with rhabdomyolysis.
I am 12 years old or older.
I can understand and sign a consent form.
You may not be able to join if
I am already taking steroids.
I cannot follow study instructions.
I have an uncontrolled illness or mental health issue.
I am pregnant.
I am younger than 40 weeks old.
I am allergic to fluconazole, clotrimazole, or nystatin.
I cannot take medications by mouth.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 s…
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.
Trial Locations
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Eligibility Criteria
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:
* Alrea…
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
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