Clinical trial NCT04422535: Effects on the Qt Interval of COVID-19 Coronavirus Infection
Official title: Observational Study to Evaluate the Effects on the Qt Interval of COVID-19 Coronavirus Infection in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Intensive Care Patients
Keywords: QT interval, ventricular repolarization
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients admitted to critical care units with COVID-19 infection
* Ages between 18-80 years
* Documentation in the clinical history sufficient to collect the data of interest to the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: incidence of arrhythmias and impact of the COVI-drugs administered on QT interval
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Anestesia, Hospital General Universitario Gregorio Marañon
Study officials:
affiliation: Hospital Universitario Gregorio Marañon
name: Javier Hortal, MD PhD
role: STUDY_CHAIR
References:
citation: Fernandes FM, Silva EP, Martins RR, Oliveira AG. QTc interval prolongation in critically ill patients: Prevalence, risk factors and associated medications. PLoS One. 2018 Jun 13;13(6):e0199028. doi: 10.1371/journal.pone.0199028. eCollection 2018.
citation: Pickham D, Helfenbein E, Shinn JA, Chan G, Funk M, Drew BJ. How many patients need QT interval monitoring in critical care units? Preliminary report of the QT in Practice study. J Electrocardiol. 2010 Nov-Dec;43(6):572-6. doi: 10.1016/j.jelectrocard.2010.05.016.
citation: Gowda RM, Khan IA, Wilbur SL, Vasavada BC, Sacchi TJ. Torsade de pointes: the clinical considerations. Int J Cardiol. 2004 Jul;96(1):1-6. doi: 10.1016/j.ijcard.2003.04.055.
citation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
citation: Shi S, Qin M, Shen B, Cai Y, Liu T, Yang F, Gong W, Liu X, Liang J, Zhao Q, Huang H, Yang B, Huang C. Association of Cardiac Injury With Mortality in Hospitalized Patients With COVID-19 in Wuhan, China. JAMA Cardiol. 2020 Jul 1;5(7):802-810. doi: 10.1001/jamacardio.2020.0950.