RhabdomyolysisRhabdoGuideNCT04118608
Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment
An observational study of Rhabdomyolysis, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhabdomyolysis
- How many people
- 310 participants
- Where
- 1 siteNorway
- Study dates
- 4 Aug 2019to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
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.
Read the 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.
- Conditions
- Rhabdomyolysis
- Being tested
- No intervention
- Medical subject headings
- Rhabdomyolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Acute Kidney Injury (AKI)
AKI will be defined according to KDIGO 2012 guidelines
Measured: Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)
Kidney function after three months and development of Chronic Kidney Disease (CKD)
Change in kreatinine and/or eGFR. CKD classifications followed KDIGO stages I-V
Measured: 3 months
Secondary outcomes (4)
Other complications
Other complications including death
Measured: During hospitalization (average 1 week)
Risk stratification based on Myoglobin/Creatine kinase ratio
Risk of AKI (see above) can be predicted based on this ratio
Measured: 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
Measured: Through hospitalization (average 1 week)
Risk stratification based on Myoglobin and Creatine kinase
See if risk of AKI (see above) can be predicted based on this
Measured: Through hospitalization (average 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start4 Aug 2019
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RhabdomyolysisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, University Hospital, Akershus
- Responsible party
- Principal investigator, Mari Asphjell Bjørnaas, Oslo University Hospital
- Investigators
- Vangstad, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118608
- Sponsor's protocol ID
- 2019/370
- Acronym
- RhabdoGuide
- Status last verified
- Mar 2025
- First submitted
- 20 Sep 2019
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vangstad M, Kro Birkeland JA, Gulsvik AK, Ervik RL, Oftebro I, Brekke FB, Akkouh OA, Jacobsen D, Bjornaas MA. Exertional rhabdomyolysis: clinical features, management, complications and prediction of acute kidney injury. BMJ Open Sport Exerc Med. 2026 Mar 3;12(1):e003214. doi: 10.1136/bmjsem-2026-003214. eCollection 2026.
PubMed 41788978Vangstad M, Gulsvik AK, Kro Birkeland JA, Ervik RL, Brekke FB, Akkouh OA, Jacobsen D, Bjornaas MA. Myoglobin-to-creatine kinase ratio enhances prediction of acute kidney injury in rhabdomyolysis. Emerg Med J. 2026 Jan 28:emermed-2025-215470. doi: 10.1136/emermed-2025-215470. Online ahead of print.
PubMed 41605622
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhabdomyolysis - a Study of Patients and Laboratory Values to Guide Treatment
- ClinicalTrials.gov ID
- NCT04118608
- Acronym / sponsor ID
- RhabdoGuide / 2019/370
- Conditions
- Rhabdomyolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, University Hospital, Akershus
- Study start
- 4 Aug 2019 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
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
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
4 secondary outcomes
Other complications
Time frame: During hospitalization (average 1 week)
Risk stratification based on Myoglobin/Creatine kinase ratio
Time frame: Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)
Association between rhabdomyolysis, elevated cardiac enzymes and the effect on myocardium.
Time frame: Through hospitalization (average 1 week)
Risk stratification based on Myoglobin and Creatine kinase
Time frame: Through hospitalization (average 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Derived from this study: PubMed 41788978Vangstad M, Kro Birkeland JA, Gulsvik AK, Ervik RL, Oftebro I, Brekke FB, Akkouh OA, Jacobsen D, Bjornaas MA. Exertional rhabdomyolysis: clinical features, management, complications and prediction of acute kidney injury. BMJ Open Sport Exerc Med. 2026 Mar 3;12(1):e003214. doi: 10.1136/bmjsem-2026-003214. eCollection 2026.
- Derived from this study: PubMed 41605622Vangstad M, Gulsvik AK, Kro Birkeland JA, Ervik RL, Brekke FB, Akkouh OA, Jacobsen D, Bjornaas MA. Myoglobin-to-creatine kinase ratio enhances prediction of acute kidney injury in rhabdomyolysis. Emerg Med J. 2026 Jan 28:emermed-2025-215470. doi: 10.1136/emermed-2025-215470. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vangstad principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhabdomyolysis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Acute Kidney Injury (AKI) (time frame: Change of creatinine from baseline (KDIGO 2012 guidelines) through hospitalization (average 1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04118608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.