Clinical trial NCT04118608: Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment
Official title: Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhabdomyolysis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Lovisenberg Diakonale Hospital
name: Diakonhjemmet Hospital
name: University Hospital, Akershus
First posted: 2019-10-08
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.

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

Primary outcomes:
measure: Development of Acute Kidney Injury (AKI)
timeFrame: Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)
measure: Kidney function after three months and development of Chronic Kidney Disease (CKD)
timeFrame: 3 months
Secondary outcomes:
measure: Other complications
timeFrame: During hospitalization (average 1 week)
measure: Risk stratification based on Myoglobin/Creatine kinase ratio
timeFrame: Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)
measure: Association between rhabdomyolysis, elevated cardiac enzymes and the effect on myocardium.
timeFrame: Through hospitalization (average 1 week)
measure: Risk stratification based on Myoglobin and Creatine kinase
timeFrame: Through hospitalization (average 1 week)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: University of Oslo
name: Vangstad
role: PRINCIPAL_INVESTIGATOR
References: