Cardiac Dysfunction in Critically Ill Patients With COVID-19

Covid19 Clinical Trial

— CARDYCOVID  

Official title:

Cardiac Dysfunction in Critically Ill Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524234
• Other study ID #: CARDY CRIT COVID
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients infected with COVID-19.

Description:

Cardiac dysfunction has been reported to be common in patients infected with COVID-19. The aim of this study is to evaluate the clinical importance of cardiac dysfunction in critically ill patients with COVID-19. Patients admitted to the intensive care unit, with COVID-19 are examined with echocardiography for assessment of left and right ventricular dysfunction within 72 hours from admission and repeated after four to seven days.

Cardiac dysfunction was defined as having either left ventricular (LV) dysfunction, defined as having an ejection fraction <50% and/or regional hypokinesia, or right ventricular (RV) dysfunction, defined as having a tricuspid annular plane excursion (TAPSE) <17mm or a moderate/severe RV dysfunction assessed visually.

The cardiac biomarkers troponin and NTproBNP and clinical data are recorded at time of each echo. Mortality status is recorded at 30 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 30, 2020
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: Patients admitted to the intensive care unit infected with COVID-19

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Covid19
• Hypertension, Pulmonary
• Left Ventricular Dysfunction
• Pulmonary Hypertension
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography for assessment of cardiac function

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götaland
Sweden	Sahlgrenska University Hospital/Mölndal	Gothenburg	Västra Götaland
Sweden	Sahlgrenska University Hospital/Östra	Gothenburg	Västra Götaland
Sweden	Södersjukhuset	Stockholm	Region Stockholm
Sweden	North Älvsborg County Hospital	Trollhättan	Västra Götalandsregionen

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All cause death in patients with vs without cardiac dysfunction	30 days
Secondary	Left ventricular dysfunction	Prevalence of left ventricular dysfunction	Within 72 hours from admission
Secondary	Right ventricular dysfunction	Prevalence of right ventricular dysfunction	Within 72 hours from admission
Secondary	Risk-factors	Clinical variables associated with risk of having cardiac dysfunction	Within 72 hours from admission
Secondary	Cardiac biomarkers	Levels of cardiac biomarkers in patients with vs without cardiac dysfunction	Within 72 hours from admission
Secondary	Left ventricular dysfunction	Prevalence of left ventricular dysfunction	During ICU-stay
Secondary	Right ventricular dysfunction	Prevalence of right ventricular dysfunction	During ICU-stay
Secondary	Risk-factors	Clinical variables associated with risk of having cardiac dysfunction	During ICU-stay
Secondary	Cardiac biomarkers	Levels of cardiac biomarkers in patients with vs without cardiac dysfunction	During ICU-stay