Skip to main content
OpenTrials
Completed

NCT Number: NCT04118608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital, Ullevaal

Oslo, 0450, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Development of Acute Kidney Injury (AKI)

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

    AKI will be defined according to KDIGO 2012 guidelines

  2. Kidney function after three months and development of Chronic Kidney Disease (CKD)

    Time frame: 3 months

    Change in kreatinine and/or eGFR. CKD classifications followed KDIGO stages I-V

Secondary outcomes

  1. Other complications

    Time frame: During hospitalization (average 1 week)

    Other complications including death

  2. Risk stratification based on Myoglobin/Creatine kinase ratio

    Time frame: 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

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

    Time frame: Through hospitalization (average 1 week)

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

  4. Risk stratification based on Myoglobin and Creatine kinase

    Time frame: Through hospitalization (average 1 week)

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Diakonhjemmet Hospital
  • Lovisenberg Diakonale Hospital
  • University Hospital, Akershus

Registry information

Acronym: RhabdoGuide

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2019
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.