NOT_YET_RECRUITING
Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
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:
🦠 Rhabdomyolysis
🗓️ Study Start (Actual) 1 October 2024
🗓️ Primary Completion (Estimated) 1 December 2025
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

  • 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
Ages Eligible for Study: 6 Months to 25 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 August 2023
  • First Submitted that Met QC Criteria 23 May 2024
  • First Posted 28 May 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 May 2024
  • Last Update Posted 28 May 2024
  • Last Verified May 2024