A Clinical Trial to Assess Whether Dexamethasone Addition to Standard Protocols for Non-Traumatic Rhabdomyolysis of Unknown or Genetic Etiologies Improves Patient Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 25
Healthy Volunteers: f
View:

• Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded

• Ability of parents/patients to understand and the willingness to sign a written informed consent document.

• Patients ages 12 and older will sign written assent

Locations
United States
Washington, D.c.
Childrens National
RECRUITING
Washington D.c.
Contact Information
Primary
Natasha Shur, MD
nshur2@childrensnational.org
202-476-5000
Backup
Natasha Shur, MD
nshur2@childrensnational.org
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute

This content was sourced from clinicaltrials.gov