Glycaemia and Cardiac Function in Patients With COVID-19

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Steno Diabetes Center Copenhagen
Updated on 5 August 2020
glycosylated hemoglobin
plasma glucose
atrial fibrillation
covid-19
hemoglobin a1c
plasma glucose measurement
diabetes
type 2 diabetes mellitus

Summary

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.

Details
Condition NIDDM, diabetes mellitus, type 2, Diabetes Mellitus, diabetes (pediatric), Insulin dependent diabetes mellitus, diabetes (pediatric), diabetes mellitus, type 2, COVID
Age 18years - 100years
Treatment Glycaemic levels
Clinical Study IdentifierNCT04410718
SponsorSteno Diabetes Center Copenhagen
Last Modified on5 August 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed and written consent
Age 18 years
Verified COVID-19
Admission to medical ward within the last 24 hours
Type 1 or type 2 diabetes prior to admission

Exclusion Criteria

Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
Pacemaker rhythm
Severe valve disease
Withdrawal criteria
The participants may withdraw at will at any time
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