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

Oslo University Hospital310 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Rhabdomyolysis

Interventions

No interventionOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * Exclusion Criteria: Acute coronary syndrome, heart failure, arrythmia, previous myocarditis, circulatory shock, acute pulmonary embolism, thoracic trauma/heart trauma or CKD before hospitalization.

Locations (1)

Oslo University Hospital, Ullevaal

Oslo, Norway

Outcomes

Primary Outcomes

Development of Acute Kidney Injury (AKI)

AKI will be defined according to KDIGO 2012 guidelines

Time frame: 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

Time frame: 3 months

Secondary Outcomes

Other complications

Other complications including death

Time frame: During hospitalization (average 1 week)

Risk stratification based on Myoglobin/Creatine kinase ratio

Risk of AKI (see above) can be predicted based on this ratio

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

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

Increased Troponin T levels and findings on echocardiography with strain and in some cardiac IMR

Time frame: Through hospitalization (average 1 week)

Risk stratification based on Myoglobin and Creatine kinase

See if risk of AKI (see above) can be predicted based on this

Time frame: Through hospitalization (average 1 week)

Data from ClinicalTrials.gov

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