跳至主要内容
临床试验/NCT04118608
NCT04118608已完成不适用

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

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2019年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
310
试验地点
1
主要终点
Development of Acute Kidney Injury (AKI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Development of Acute Kidney Injury (AKI)

时间窗: 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)

时间窗: 3 months

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

次要结局

  • Other complications(During hospitalization (average 1 week))
  • Risk stratification based on Myoglobin/Creatine kinase 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.(Through hospitalization (average 1 week))
  • Risk stratification based on Myoglobin and Creatine kinase(Through hospitalization (average 1 week))

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mari Asphjell Bjørnaas

Project manager

Oslo University Hospital

研究点 (1)

Loading locations...

相似试验