RhabdomyolysisRYRNCT06101680
RhabdomYolyse in Intensive caRe
An observational study of Rhabdomyolysis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with severe rhabdomyolysis (> 5000 UI/L) hospitalized in intensive care unit.
Who may be able to join
- CPK > 5000 UI/L
- Care in Pediatric Intensive Care Unit
- Age < 18 years old
Who cannot join
- Parental refusal
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Rhabdomyolysis
- Keywords
- rhabdomyolysis, child, Intensive Care
- Medical subject headings
- Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children in intensive care with rhabdomyosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of renal remplacement therapy
Use of renal remplacement therapy in case of severe rhabdomyolysis in children in intensive care unit
Measured: 7 days after admission in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnaud WIEDEMANN-FODE, Central Hospital, Nancy, France
- Investigators
- Arnaud Wiedemann, MD PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101680
- Sponsor's protocol ID
- 2022PI201
- Acronym
- RYR
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RhabdomYolyse in Intensive caRe
- ClinicalTrials.gov ID
- NCT06101680
- Acronym / sponsor ID
- RYR / 2022PI201
- Conditions
- Rhabdomyolysis
- Keywords
- rhabdomyolysis, child, Intensive Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children in intensive care with rhabdomyosis | – | – |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with severe rhabdomyolysis (> 5000 UI/L) hospitalized in intensive care unit.
Key inclusion criteria (3 listed)
- CPK > 5000 UI/L
- Care in Pediatric Intensive Care Unit
- Age < 18 years old
Key exclusion criteria (1 listed)
- Parental refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Wiedemann, MD PhD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of renal remplacement therapy (time frame: 7 days after admission in intensive care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.