Rhabdomyolysis - a Study of Patient Characteristics and Laboratory Values to Guide Treatment

Rhabdomyolysis Clinical Trial

Official title:

Rhabdomyolysis - a Study of Patient Characteristics and Laboratory Values to Guide Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118608
• Other study ID #: 2019/370
• Status: Completed
• Start date: August 4, 2019
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhabdomyolysis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Diakonhjemmet Hospital, Lovisenberg Diakonale Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)