Glycaemia and Cardiac Function in Patients With COVID-19

NCT ID: NCT04410718

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-20
• Study Completion Date: 2021-06-30

Brief 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

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; COVID

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The intensive care unit cohort

Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit

Glycaemic levels

Intervention Type: OTHER

Glycaemic levels during admission for COVID-19

The hospitalisation cohort

Patients with diabetes and COVID-19 admitted to the medical ward

Glycaemic levels

Intervention Type: OTHER

Glycaemic levels during admission for COVID-19

Interventions

Glycaemic levels

Glycaemic levels during admission for COVID-19

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed and written consent
• Age ≥18 years
• Verified COVID-19
• Admission to the ICU within the last 24 hours
• Type 1 or type 2 diabetes prior to admission (the diabetes sub-group only)

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Andreas Andersen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Herlev and Gentofte Hospital

Hellerup, Please Select, Denmark

Hvidovre Hospital

Hvidovre, Please Select, Denmark

Countries

Denmark

Other Identifiers

H-20024279

Identifier Type: -

Identifier Source: org_study_id