Rhabdomyolysis
Conditions
Brief 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.
Detailed description
Study Objective: This is a single center, 2-year, blinded prospective randomized study for those diagnosed with rhabdomyolysis age six months-25 years using dexamethasone versus placebo treatment in addition to standard care in up to 50 patients. Study Design: Patients will be enrolled with a 2:1 ratio of treatment of dexamethasone for 5 days versus placebo treatment for 5 days in addition to receiving standard care. The treatment period for each subject will be five days treatment with oral treatment once per day with study drug (dexamethasone versus placebo). All patients will also receive standard care. Patients and their parent/ caregiver will have the option to complete surveys before and after treatment in order to assess pain level and treatment improvement. Chart review will be performed on all patients throughout and after the five-day study treatment period. There will be no additional interventions.
Interventions
DRUGDexamethasone
Steroid five day treatment
DRUGPlacebo
Placebo control group
Sponsors
Children's National Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study will be double-blinded. The pharmacy will determine which patients are in the study group.
Intervention model description
There will be a 2: 1 treatment ratio of dexamethasone treated group versus placebo.
Eligibility
Sex/Gender
ALL
Age
6 Months to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of rhabdomyolysis defined as creatine kinase\> 5000 with trauma excluded 2. Ability of parents/patients to understand and the willingness to sign a written informed consent document. 3. Patients ages 12 and older will sign written assent
Exclusion criteria
* 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. o A urine pregnancy test will be performed for women of child-bearing potential. * Below gestational age of 40 weeks * Allergy to fluconazole, clotrimazole or nystatin. * Cannot tolerate PO medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Primarily 5 days - 1 year | Number of days Length of Stay in Each Group |
| Muscle breakdown | Primarily 5 days - 1 year | Creatinine Kinase trend comparison between groups |
| Renal complications | Primarily 5 days - 1 year | Bun/ Creatinine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative Pain Outcomes | 14 days | EHR pain scores |
Countries
United States
Contacts
Primary ContactNatasha Shur, MD
Backup ContactNatasha Shur, MD
Outcome results
None listed