NCT06101680

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 16, 2023

Last Update Submit

October 20, 2023

Conditions

Rhabdomyolysis

Keywords

rhabdomyolysischildIntensive Care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Children in intensive care with rhabdomyosis

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Parental refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reanimation Pediatrique

Nancy, 54000, France

Location

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Arnaud Wiedemann, MD PhD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 26, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations

FR(1)