Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Conditions

• Rhabdomyolysis

Eligibility Criteria

Sex

ALL

Age

6 Months - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Dexamethasone — DRUG
  Steroid five day treatment
• Placebo — DRUG
  Placebo control group

Study Details

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.

Key Dates

Start date

Oct 1, 2024

Status verified

Jul 2025

Primary completion

Dec 1, 2025

Completion

Dec 31, 2026

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Dexamethasone group
  Dexamethasone five days with 0.6 mg/ kg dose per day max 16 mg dose. Standard care will also be provided.
• Placebo Comparator: Placebo group
  Placebo for five days with one dose per day placebo oral dosing. Standard care will also be provided.

Primary Outcome Measure

Length of Stay [ Time Frame: Primarily 5 days - 1 year ]

Central Contacts

• Natasha Shur, MD
  202-476-5000
  [email protected]
• Natasha Shur, MD
  [email protected]

Locations (1)

Find similar trials in Washington D.C., DC

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