Effects on the Qt Interval of COVID-19 Coronavirus Infection

• Conditions: Intensive Care Patients; Coronavirus Infection

• Registration Number: NCT04422535
• Lead Sponsor: Matilde Zaballos

Brief Summary

The present study aims to evaluate the impact of COVID-19 disease and its treatment on ventricular repolarization, assessed by measuring the QTc interval, in patients admitted to the critical care unit.

Detailed Description

Coronavirus infection of Severe Acute Respiratory Syndrome COVID-2 is characterized by a broad clinical spectrum ranging from asymptomatic infection, mild upper respiratory tract disease and severe viral pneumonia with respiratory failure and even death, with many patients hospitalized with pneumonia. In addition, the infection can have a direct impact on cardiovascular disease including the development of arrhythmias, although the exact incidence is not known. Treatments administered for COVID-19 infection have the potential to produce adverse cardiovascular effects including prolongation of the QT interval and development of arrhythmias.

Relevant clinical data that may affect the QT interval and specifically the medication the patient has received will be recorded. The specific treatment administered for COVID-19 will be recorded as the concomitant medication of the critical patient that may have an impact on the QT interval. Analytical data will also be collected on plasma levels of ions such as potassium, calcium and magnesium, blood gases, renal and hepatic function parameters and cardiac markers.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-29
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-09
• Last Update Posted: 2020-06-09
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients admitted to intensive care units for COVID-19 infection with an ECG record

Exclusion Criteria

• Patients in critical care unit without COVID-19 infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection	through study completion, an average of 1 year	The QT interval measurement will be performed on the available 12-lead ECG from the medical record. The QT interval will be measured according to the recommendations of the scientific societies of cardiology: it is considered from the beginning of the activation of the ventricular myocardium and the end of its repolarization, which are represented in the ECG respectively by the beginning of the QRS and the end of the T wave. Ideally, the QT interval should be measured in Q-wave leads in DII and V5. An average value of 3 heart cycles (beats) should be recorded. Two researchers to control inter-observer variability will perform the measurement.

Secondary Outcome Measures

Name	Time	Method
incidence of arrhythmias and impact of the COVI-drugs administered on QT interval	through study completion, an average of 1 year	To assess the incidence of arrhythmias in critically ill patients with COVID-19 infection admitted to critical patient units.; To evaluate the impact of the association of drugs administered for the treatment of COVID-19 infection in critically ill patients in the QT interval.

Trial Locations

Locations (1)

Servicio de Anestesia, Hospital General Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain