RhabdomYolyse in Intensive caRe | NCT06101680

Studies
RhabdomYolyse in Intensive caRe

NCT06101680

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Oct 26, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Rhabdomyolysis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Actual

Primary Completion Date

Dec 1, 2023Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

Oct 16, 2023

First Submission Date that Met QC Criteria

Oct 20, 2023

First Posted Date

Oct 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2023

Last Update Posted Date

Oct 26, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arnaud WIEDEMANN-FODE, Clinical Professor, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Label	Type	Description	Intervention Names
Children in intensive care with rhabdomyosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Use of renal remplacement therapy	Use of renal remplacement therapy in case of severe rhabdomyolysis in children in intensive care unit	7 days after admission in intensive care unit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CPK > 5000 UI/L
Care in Pediatric Intensive Care Unit
Age < 18 years old

Exclusion Criteria:

Parental refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children with severe rhabdomyolysis (> 5000 UI/L) hospitalized in intensive care unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud Wiedemann, MD PhD	CHRU Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reanimation Pediatrique		Nancy		54000	France

Condition Browse Module

MeSH Terms

ID	Term
D012206	Rhabdomyolysis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided