Clinical trial NCT04524234: Cardiac Dysfunction in Critically Ill Patients With COVID-19
Official title: Cardiac Dysfunction in Critically Ill Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Left Ventricular Dysfunction
Right Ventricular Dysfunction
Pulmonary Hypertension
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to participating unit, being infected with COVID-19 are eligible for inclusion

Brief 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.

Detailed 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.

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

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Left ventricular dysfunction
timeFrame: Within 72 hours from admission
measure: Right ventricular dysfunction
timeFrame: Within 72 hours from admission
measure: Risk-factors
timeFrame: Within 72 hours from admission
measure: Cardiac biomarkers
timeFrame: Within 72 hours from admission
measure: Left ventricular dysfunction
timeFrame: During ICU-stay
measure: Right ventricular dysfunction
timeFrame: During ICU-stay
measure: Risk-factors
timeFrame: During ICU-stay
measure: Cardiac biomarkers
timeFrame: During ICU-stay
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
state: Region Stockholm
city: Trollhättan
country: Sweden
facility: North Älvsborg County Hospital
state: Västra Götalandsregionen
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital/Mölndal
state: Västra Götaland
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital/Östra
state: Västra Götaland
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Jonatan Oras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: