RECRUITING

Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06429982

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Already taking systemic steroids.
  2. * Inability to comply with study instructions.
  3. * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  4. * Pregnant women.
  5. * Below gestational age of 40 weeks
  6. * Allergy to fluconazole, clotrimazole or nystatin.
  7. * Cannot tolerate PO medications

Contacts and Locations

Study Contact

Natasha Shur, MD
CONTACT
202-476-5000
nshur2@childrensnational.org
Natasha Shur, MD
CONTACT
nshur2@childrensnational.org

Principal Investigator

Natasha Shur, MD
PRINCIPAL_INVESTIGATOR
Children's National Research Institute

Study Locations (Sites)

Childrens National
Washington DC, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Natasha Shur, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Rhabdomyolysis