Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Plasma glucose levels and left ventricular ejection fraction |
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) |
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). |
|
| Secondary |
Key secondary outcome: HbA1c, plasma glucose levels and left ventricular systolic function |
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c =53 mmol/l) (ICU cohort only) |
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). |
|
| Secondary |
Plasma glucose levels and strain analysis |
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis (a pooled analysis of the hospitalisation cohort and ICU cohort) |
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). |
|
| Secondary |
Plasma glucose levels and mitral annular systolic velocity |
The within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity (a pooled analysis of the hospitalisation cohort and ICU cohort) |
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). |
|
| Secondary |
Plasma glucose levels and left ventricular ejection fraction (sub-group analysis) |
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by left ventricular ejection fraction between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively |
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). |
|
| Secondary |
Plasma glucose levels and strain analysis (sub-group analysis) |
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively |
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). |
|
| Secondary |
Plasma glucose levels and mitral annular systolic velocity (sub-group analysis) |
Differences in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between the hospitalisation cohort, the ICU cohort with diabetes and the ICU cohort without diabetes, respectively |
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). |
|
| Secondary |
HbA1c, Plasma glucose levels and strain analysis |
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by strain analysis between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c =53 mmol/l) (ICU cohort only) |
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). |
|
| Secondary |
HbA1c, Plasma glucose levels and mitral annular systolic velocity |
Difference in the within-subject effect of plasma glucose levels on left ventricular systolic function as measured by mitral annular systolic velocity between patients with chronic hyperglycaemia prior to admission (HbA1c >53 mmol/mol) and with normoglycaemia prior to admission (HbA1c =53 mmol/l) (ICU cohort only) |
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). |
|
| Secondary |
Diabetes status and whole blood coagulability and fibrinolysis |
Difference in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes at time of admission to the ICU (ICU cohort only) |
At time of admission to the ICU (max. 24 hours after admission to the ICU) |
|
| Secondary |
Diabetes status and change in whole blood coagulability and fibrinolysis during ICU stay |
Difference in change in whole blood coagulability and fibrinolysis as measured by TEG between patients with and without diabetes treated at the ICU (ICU cohort only) |
From first until last assessment during ICU stay (max. 24 hours). |
|
| Secondary |
Prognostic value of TEG analysis |
The prognostic value of cardiac function and TEG on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death |
From time of admission and until four weeks after admission |
|
| Secondary |
Prognostic value of cardiac function |
The prognostic value of cardiac function on the following patient outcomes 1) need for treatment in the ICU (hospitalisation cohort only) 2) need for respirator treatment (hospitalisation cohort only) 3) COVID-19 related death |
From time of admission and until four weeks after admission |
|
| Secondary |
Diabetes status and high-sensitivity troponins |
Difference in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only) |
At the time of admission to the ICU (max. 24 hours after admission to the ICU) |
|
| Secondary |
Diabetes status and change high-sensitivity troponins |
Difference in change in cardiac damage as measured by high-sensitivity troponin (hs-troponin) between patients with and without diabetes admitted to the ICU (ICU cohort only) |
From first until last assessment during ICU stay (max. 24 hours) |
|
