Glycaemia and Cardiac Function in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Plasma glucose levels and left ventricular ejection fraction
研究概览
简要总结
The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort).
The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Plasma glucose levels and left ventricular ejection fraction
时间窗: The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction (a pooled analysis of the hospitalisation cohort and ICU cohort)
次要结局
- Plasma glucose levels and strain analysis(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Plasma glucose levels and mitral annular systolic velocity (sub-group analysis)(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Plasma glucose levels and left ventricular ejection fraction (sub-group analysis)(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- HbA1c, Plasma glucose levels and mitral annular systolic velocity(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Diabetes status and whole blood coagulability and fibrinolysis(At time of admission to the ICU (max. 24 hours after admission to the ICU))
- Plasma glucose levels and mitral annular systolic velocity(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Plasma glucose levels and strain analysis (sub-group analysis)(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- HbA1c, Plasma glucose levels and strain analysis(The study applies a mixed model for assessment of within-subject effects by repeated assessment in same individual. The time frame is from first assessment until last assessment (max. 24 hours).)
- Prognostic value of TEG analysis(From time of admission and until four weeks after admission)
- Diabetes status and change high-sensitivity troponins(From first until last assessment during ICU stay (max. 24 hours))
- Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay(From first until last assessment during ICU stay (max. 24 hours).)
- Prognostic value of cardiac function(From time of admission and until four weeks after admission)
- Diabetes status and high-sensitivity troponins(At the time of admission to the ICU (max. 24 hours after admission to the ICU))
研究者
Andreas Andersen
Principal Investigator
Steno Diabetes Center Copenhagen