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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Completed

Conditions

Rhabdomyolysis

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04118608
2019/370

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Central trial contact

Vangstad; Bjornaas

Data sourced from clinicaltrials.gov

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