Rhabdomyolysis - a Study of Patient Characteristics 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.

Study Overview

• Status: Completed
• Conditions: Rhabdomyolysis
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 310

Contacts and Locations

• Study Contact: Name: Vangstad; Phone Number: +47 90824669; Email: marievangstad@outlook.com
• Study Contact Backup: Name: Bjornaas; Phone Number: +47 91560382; Email: mabjornaas@gmail.com

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital, Ullevaal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of Acute Kidney Injury (AKI)	AKI will be defined according to KDIGO 2012 guidelines	Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk stratification based on Myoglobin/Creatinine kinase ratio	Risk of AKI (see above) can be predicted based on this ratio	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	Through hospitalization (average 1 week)

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Diakonhjemmet Hospital; University Hospital, Akershus; Lovisenberg Diakonale Hospital
• Investigators: Principal Investigator: Vangstad, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2019
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Rhabdomyolysis
• Other Study ID Numbers: 2019/370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No