NCT03737513

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。

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

November 8, 2018

Last Update Submit

June 23, 2019

Conditions

Rhabdomyolysis

Keywords

RhabdomyolysisMilitary Training

Outcome Measures

Primary Outcomes (2)

  • serum creatine kinase；

    Change in serum creatine kinase at 3 months

    3 months

  • serum myoglobin

    At the time of discharge

    1 week

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Students who participated in this military training from the same school

You may qualify if:

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

You may not qualify if:

  • Caused by drugs and other reasons;
  • No hospitalization event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yueqing Hospital Affiliated to Wenzhou Medical University

Yueqing, Zhejiang, 325600, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, urine

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 9, 2018

Study Start

September 9, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 25, 2019

Record last verified: 2019-06

Locations

CN(1)