Effects on the Qt Interval of COVID-19 Coronavirus Infection

NCT ID: NCT04422535

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-29

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Coronavirus Infection Intensive Care Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Critical care patients

Patients admitted to critical care units for COVID-19, where ECG records and relevant clinical information are available to assess the impact of the disease and its concomitant treatment on electrocardiographic parameters of ventricular repolarization

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matilde Zaballos

OTHER

Sponsor Role lead

Responsible Party

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Matilde Zaballos

specialist physician at Anesthesiology Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Javier Hortal, MD PhD

Role: STUDY_CHAIR

Hospital Universitario Gregorio Marañon

Locations

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Servicio de Anestesia, Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Matilde Zaballos, MDPhD

Role: CONTACT

0034657813987

Javier Hortal, MD PhD

Role: CONTACT

915868367

Facility Contacts

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Matilde Zaballos, MD, PhD

Role: primary

0034915868367

References

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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.

Reference Type RESULT
PMID: 29898002 (View on PubMed)

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.

Reference Type RESULT
PMID: 21040827 (View on PubMed)

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.

Reference Type RESULT
PMID: 15203254 (View on PubMed)

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.

Reference Type RESULT
PMID: 32031570 (View on PubMed)

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.

Reference Type RESULT
PMID: 32211816 (View on PubMed)

Other Identifiers

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QT-COVID-19

Identifier Type: -

Identifier Source: org_study_id

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