Trials / Completed
CompletedNCT04410718
Glycaemia and Cardiac Function in Patients With COVID-19
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- Steno Diabetes Center Copenhagen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Glycaemic levels | Glycaemic levels during admission for COVID-19 |
Timeline
- Start date
- 2020-04-20
- Primary completion
- 2021-06-30
- Completion
- 2021-06-30
- First posted
- 2020-06-01
- Last updated
- 2022-11-29
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04410718. Inclusion in this directory is not an endorsement.