Dexamethasone for Rhabdomyolysis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding dexamethasone, a type of steroid, to standard care can help people with rhabdomyolysis recover faster and reduce kidney problems. Rhabdomyolysis occurs when muscle tissue breaks down, releasing creatine kinase into the blood, which can cause pain and kidney issues. The trial includes two groups: one receiving dexamethasone and the other a placebo, both alongside standard care. Suitable candidates for this trial are individuals aged 12 and up with rhabdomyolysis and creatine kinase levels above 5000, not caused by trauma. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking systemic steroids.
Is there any evidence suggesting that dexamethasone is likely to be safe for humans?
Research has shown that dexamethasone has been tested in animals for conditions like Crush syndrome, which resemble rhabdomyolysis. These studies found better outcomes without major safety issues. In humans, dexamethasone has been used safely for other conditions, but it is not yet a standard treatment for rhabdomyolysis. Some studies on children with rhabdomyolysis of unknown cause have shown encouraging results with few side effects. Since this trial is in an early stage, it primarily focuses on safety. The FDA has already approved dexamethasone for other uses, which provides some reassurance about its safety.12345
Why do researchers think this study treatment might be promising?
Most treatments for rhabdomyolysis focus on hydration and correcting electrolyte imbalances. However, Dexamethasone is unique because it leverages its anti-inflammatory properties to potentially reduce muscle damage more directly. This steroid is used to help control inflammation, which could be crucial in managing the muscle breakdown that characterizes rhabdomyolysis. Researchers are excited because this approach might offer a faster, more targeted way to address the condition, possibly improving recovery times and outcomes compared to standard care.
What evidence suggests that dexamethasone might be an effective treatment for rhabdomyolysis?
Research shows that dexamethasone, a type of steroid, might help treat rhabdomyolysis, a condition where muscle tissue breaks down and can damage the kidneys. In this trial, participants in the dexamethasone group will receive dexamethasone for five days. Studies have found that dexamethasone can shorten the active phase of rhabdomyolysis and reduce the time patients need to stay in intensive care. This could lead to faster recovery and less time in the hospital. Although not yet a standard treatment, early results are promising and suggest that dexamethasone could improve recovery for people with rhabdomyolysis.36789
Who Is on the Research Team?
Natasha Shur, MD
Principal Investigator
Children's National Research Institute
Are You a Good Fit for This Trial?
This trial is for children with rhabdomyolysis, a muscle breakdown condition. It's open to those who meet certain health criteria but details on specific inclusions or exclusions aren't provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dexamethasone or placebo for 5 days in addition to standard care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain assessment and chart review
Extended Follow-up
Participants are monitored for long-term outcomes such as length of hospital stay and renal complications
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's National Research Institute
Lead Sponsor