- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101680
RhabdomYolyse in Intensive caRe (RYR)
October 20, 2023 updated by: Arnaud WIEDEMANN-FODE, Central Hospital, Nancy, France
Analysis of the outcome of patients < 18 years old, treated in an intensive care unit for severe rhabdomyolysis, regardless of etiology (renal failure rate, death rate, organ replacement rate)
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nancy, France, 54000
- Reanimation Pediatrique
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children with severe rhabdomyolysis (> 5000 UI/L) hospitalized in intensive care unit.
Description
Inclusion Criteria:
- CPK > 5000 UI/L
- Care in Pediatric Intensive Care Unit
- Age < 18 years old
Exclusion Criteria:
- Parental refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Children in intensive care with rhabdomyosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of renal remplacement therapy
Time Frame: 7 days after admission in intensive care unit
|
Use of renal remplacement therapy in case of severe rhabdomyolysis in children in intensive care unit
|
7 days after admission in intensive care unit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arnaud Wiedemann, MD PhD, CHRU Nancy
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 Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
October 16, 2023
First Submitted That Met QC Criteria
October 20, 2023
First Posted (Actual)
October 26, 2023
Study Record Updates
Last Update Posted (Actual)
October 26, 2023
Last Update Submitted That Met QC Criteria
October 20, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rhabdomyolysis
-
Martin Army Community HospitalCompleted
-
University of North Carolina, Chapel HillCompletedMuscle Strength | Muscle Dysfunction | Exertional RhabdomyolysisUnited States
-
Haitao TuYueqing Hospital Affiliated to Wenzhou Medical UniversityCompleted
-
Royal Alexandra HospitalUniversity of Alberta; Gambro Renal Products, Inc.CompletedRhabdomyolysisCanada, Saudi Arabia
-
Sheba Medical CenterUnknownRhabdomyolysisIsrael
-
Children's National Research InstituteNot yet recruitingRhabdomyolysisUnited States
-
Oslo University HospitalDiakonhjemmet Hospital; University Hospital, Akershus; Lovisenberg Diakonale...Completed
-
CytoSorbents, IncSan Antonio Military Medical Center (SAMMC), US Army Institute of Surgical...WithdrawnRhabdomyolysisUnited States
-
University of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Assistance Publique - Hôpitaux de ParisCompletedRhabdomyolysis Linked to a Hereditary Disease of MetabolismFrance