Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429982
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2023-08-31
Brief Title:
Dexamethasone Use in Pediatric Rhabdomyolysis Patients in Addition to Standard Protocols
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 21 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
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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None