Exercise-induced Collective Rhabdomyolysis | NCT03737513

Studies
Exercise-induced Collective Rhabdomyolysis

NCT03737513

Sponsor

Haitao Tu

Status

Completed

Last Update Posted

Jun 25, 2019Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Rhabdomyolysis

Interventions

Not provided

Countries

China

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

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2018Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

May 31, 2019Actual

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 8, 2018

First Posted Date

Nov 9, 2018Actual

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

Jun 23, 2019

Last Update Posted Date

Jun 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Haitao Tu, Attending physician, The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineSponsor-Investigator

Lead Sponsor

Haitao TuOTHER

Collaborators

Name	Class
Yueqing Hospital Affiliated to Wenzhou Medical University	UNKNOWN

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

Rhabdomyolysis, which is a characteristic occurrence in associated with muscle cell necrosis, develops due to various causes.The investigators herein report a rare case of collective rhabdomyolysis after high intensity resistance training, including 35 teenagers（participants），in which markedly elevated levels of serum creatine kinase (CK) and serum myoglobin were observed. This high intensity resistance trainings is a part of Military Training(MT)，which all the middle school students must finish before admission。

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

Retention

Enrollment

35Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum creatine kinase；	Change in serum creatine kinase at 3 months	3 months
serum myoglobin	At the time of discharge	1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of rhabdomyolysis;
Caused by military training;
Informed consent；
Must be able to cooperate with blood test.

Exclusion Criteria:

Caused by drugs and other reasons;
No hospitalization event

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Students who participated in this military training from the same school

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yueqing Hospital Affiliated to Wenzhou Medical University		Yueqing	Zhejiang	325600	China

Condition Browse Module

MeSH Terms

ID	Term
D012206	Rhabdomyolysis

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

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Browse Branches

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