NCT04118608

Brief Summary

Rhabdomyolysis is a potentially life-threatening syndrome characterized by breakdown of skeletal muscle, and leakage of intracellular substances such as myoglobin and creatine kinase (CK) into the circulation. The aetiological spectrum of rhabdomyolysis is extensive, and the clinical spectrum varies from a transient subclinical increase in CK activity to acute kidney injury (AKI) as a serious complication. There are no large prospective studies and only a few retrospective studies on rhabdomyolysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

4.4 years

First QC Date

September 20, 2019

Last Update Submit

March 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Development of Acute Kidney Injury (AKI)

    AKI will be defined according to KDIGO 2012 guidelines

    Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)

  • Kidney function after three months and development of Chronic Kidney Disease (CKD)

    Change in kreatinine and/or eGFR. CKD classifications followed KDIGO stages I-V

    3 months

Secondary Outcomes (4)

  • Other complications

    During hospitalization (average 1 week)

  • Risk stratification based on Myoglobin/Creatine kinase ratio

    Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)

  • Association between rhabdomyolysis, elevated cardiac enzymes and the effect on myocardium.

    Through hospitalization (average 1 week)

  • Risk stratification based on Myoglobin and Creatine kinase

    Through hospitalization (average 1 week)

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a prospective observational cohort study on patients with rhabdomyolysis admitted to emergency departments. Both medical and surgical/trauma departments will be included.

You may not qualify if:

  • Sub-study on rhabdomyolysis and cardiac enzymes:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Ullevaal

Oslo, 0450, Norway

Location

Related Publications (1)

  • Vangstad M, Gulsvik AK, Kro Birkeland JA, Ervik RL, Brekke FB, Akkouh OA, Jacobsen D, Bjornaas MA. Myoglobin-to-creatine kinase ratio enhances prediction of acute kidney injury in rhabdomyolysis. Emerg Med J. 2026 Jan 28:emermed-2025-215470. doi: 10.1136/emermed-2025-215470. Online ahead of print.

MeSH Terms

Conditions

Rhabdomyolysis

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Vangstad

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project manager

Study Record Dates

First Submitted

September 20, 2019

First Posted

October 8, 2019

Study Start

August 4, 2019

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations