Cardiac Dysfunction in Critically Ill Patients With COVID-19

Completed

• Conditions: Left Ventricular Dysfunction; Right Ventricular Dysfunction; Pulmonary Hypertension; Covid19

• Registration Number: NCT04524234
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2020-04-20
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Primary Completion: 2020-08-31
• Study Completion: 2020-09-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	All cause death in patients with vs without cardiac dysfunction

Secondary Outcome Measures

Name	Time	Method
Left ventricular dysfunction	During ICU-stay	Prevalence of left ventricular dysfunction
Right ventricular dysfunction	During ICU-stay	Prevalence of right ventricular dysfunction
Risk-factors	During ICU-stay	Clinical variables associated with risk of having cardiac dysfunction
Cardiac biomarkers	During ICU-stay	Levels of cardiac biomarkers in patients with vs without cardiac dysfunction

Trial Locations

Locations (5)

Sahlgrenska University Hospital/Mölndal; 🇸🇪 Gothenburg, Västra Götaland, Sweden

Södersjukhuset; 🇸🇪 Stockholm, Region Stockholm, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden

Sahlgrenska University Hospital/Östra; 🇸🇪 Gothenburg, Västra Götaland, Sweden

North Älvsborg County Hospital; 🇸🇪 Trollhättan, Västra Götalandsregionen, Sweden