Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment
- Conditions
- Rhabdomyolysis
- Registration Number
- NCT04118608
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
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. *
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 months Change in kreatinine and/or eGFR. CKD classifications followed KDIGO stages I-V
- Secondary Outcome Measures
Name Time Method Other complications During hospitalization (average 1 week) Other complications including death
Risk stratification based on Myoglobin/Creatine kinase ratio Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week) Risk of AKI (see above) can be predicted based on this ratio
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
Risk stratification based on Myoglobin and Creatine kinase Through hospitalization (average 1 week) See if risk of AKI (see above) can be predicted based on this
Trial Locations
- Locations (1)
Oslo University Hospital, Ullevaal
🇳🇴Oslo, Norway