Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118608
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
Lovisenberg Diakonale Hospital
Diakonhjemmet Hospital
University Hospital, Akershus
Information provided by (Responsible Party):
Mari Asphjell Bjørnaas, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment
Rhabdomyolysis 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 291 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Rhabdomyolysis - a Study of Patient Characteristics and Laboratory Values to Guide Treatment
Actual Study Start Date : August 4, 2019
Estimated Primary Completion Date : August 2027
Estimated Study Completion Date : August 2027

Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. Risk stratification based on Myoglobin/Creatinine 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

  2. Chronic kidney injury (CKI) after rhabdomyolysis [ Time Frame: 5 years (control 3 months, 1 year and 5 years after hospitalization) ]
    CKI is defined as decreased eGFR or proteinuria compared to base level

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 outcome after AKI:

    • Inclusion Criteria: Patients with kreatinin above reference/eGFR under 90mL/min/1.73m2 or proteinuria (dipstick, urine albumin, protein, albumin/creatinine ratio above normal limit) at discharge will be included in the outcome study.
    • Exclusion Criteria: Patients with chronic kidney failure but no deterioration in eGFR at discharge will not be included. Patients without Norwegian social security number will be excluded.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118608


Contacts
Layout table for location contacts
Contact: Vangstad +47 90824669 marievangstad@outlook.com
Contact: Bjornaas +47 91560382 mabjornaas@gmail.com

Locations
Layout table for location information
Norway
Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0450
Contact: Jacobsen    +47 48061155    uxdaja@ous-hf.no   
Contact: Bjornaas    +47 91560382    mabjornaas@gmail.com   
Sponsors and Collaborators
Oslo University Hospital
Lovisenberg Diakonale Hospital
Diakonhjemmet Hospital
University Hospital, Akershus
Investigators
Layout table for investigator information
Principal Investigator: Vangstad University of Oslo

Layout table for additonal information
Responsible Party: Mari Asphjell Bjørnaas, Project manager, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04118608     History of Changes
Other Study ID Numbers: 2019/370
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhabdomyolysis
Muscular Diseases
Musculoskeletal Diseases