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Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment

Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04118608
Acronym
RhabdoGuide
Enrollment
310
Registered
2019-10-08
Start date
2019-08-04
Completion date
2023-12-22
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhabdomyolysis

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.

Detailed description

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. The project will give much needed information about incidence, aetiologies and the clinical course of rhabdomyolysis. The main objective will be to study rhabdomyolysis with focus on the development of AKI and how laboratory values can guide treatment, and thus act as basis for guidelines. More knowledge is needed about rhabdomyolysis and long-term kidney injury, and the study will aim to identify a risk population for later kidney injury, thus being able to refer this group to follow-up and prevent further injury. On the other hand, exercise-induced rhabdomyolysis patients are probably hospitalized more than necessary these days, and over-treatment could be prevented if better guidelines were obtained. The possible cardiotoxicity of myoglobin needs further study, and would benefit the patient group but also fill a knowledge gap for the clinicians. Therefore, this project will ideally obtain new knowledge for the health services, potentially improve existing practice and fill important knowledge gaps.

Interventions

OTHERNo intervention

No intervention

Sponsors

Lovisenberg Diakonale Hospital
CollaboratorOTHER
Diakonhjemmet Hospital
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Main study: * Inclusion Criteria: Patients age 18 years and older, with a muscle injury developed before hospitalization and serum CK activity ≥5000 U/L and/or serum myoglobin concentrations ≥1000 ng/ml within 72 hours after admission will be included. *

Exclusion criteria

Patients with unknown identity will be excluded. 2. Sub-study on rhabdomyolysis and cardiac enzymes: * Inclusion Criteria: All patients with troponins over 14 ng/L and who otherwise fulfills the inclusion criteria can be included. *

Design outcomes

Primary

MeasureTime frameDescription
Development of Acute Kidney Injury (AKI)Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)AKI will be defined according to KDIGO 2012 guidelines
Kidney function after three months and development of Chronic Kidney Disease (CKD)3 monthsChange in kreatinine and/or eGFR. CKD classifications followed KDIGO stages I-V

Secondary

MeasureTime frameDescription
Association between rhabdomyolysis, elevated cardiac enzymes and the effect on myocardium.Through hospitalization (average 1 week)Increased Troponin T levels and findings on echocardiography with strain and in some cardiac IMR
Other complicationsDuring hospitalization (average 1 week)Other complications including death
Risk stratification based on Myoglobin/Creatine kinase ratioChange of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)Risk of AKI (see above) can be predicted based on this ratio
Risk stratification based on Myoglobin and Creatine kinaseThrough hospitalization (average 1 week)See if risk of AKI (see above) can be predicted based on this

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026