Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age6-25
SponsorChildren's National Research Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

    Steroid five day treatment

  • Placebo

    Drug

    Placebo control group

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Dexamethasone groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of Stay

Number of days Length of Stay in Each Group

Time frame
Primarily 5 days - 1 year
2

Muscle breakdown

Creatinine Kinase trend comparison between groups

Time frame
Primarily 5 days - 1 year
3

Renal complications

Bun/ Creatinine

Time frame
Primarily 5 days - 1 year

Secondary outcomes

1

Quantitative Pain Outcomes

EHR pain scores

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.