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

Study of Dexamethasone Added to Standard Care for Children and Young Adults With Non-Traumatic Rhabdomyolysis to Improve Recovery and Reduce Kidney Problems

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

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

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 21 ratio to receive either dexamethasone or a placebo once daily for five days, along with standard care. The dexamethasone dose is 0.6 mgkg 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

Research Team

N

Natasha Shur, MD

N

Natasha Shur, MD

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