Recruiting
Phase 1

Dexamethasone

Sponsor:

Children's National Research Institute

Code:

NCT06429982

Conditions

Rhabdomyolysis

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Placebo

Study Details

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.

Conditions

Rhabdomyolysis

Study ID

NCT06429982

Start date

Oct 1, 2024

Status verified date

Jul, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Dexamethasone

Steroid five day treatment

Placebo

Placebo control group

Primary outcome measure

  • Length of Stay [ Time Frame: Primarily 5 days - 1 year ]
  • Muscle breakdown [ Time Frame: Primarily 5 days - 1 year ]
  • Renal complications [ Time Frame: Primarily 5 days - 1 year ]

Central Contacts and Locations

Central contacts

Natasha Shur, MD

202-476-5000nshur2@childrensnational.org

Natasha Shur, MD

nshur2@childrensnational.org

Locations

Childrens National

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Natasha Shur

202 545-2515nshur2@childrensnational.org

Seth Berger

202 476-6156sberger@childrensnational.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Jul 3, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-07-03.