NCT04422535

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

June 3, 2020

Last Update Submit

June 5, 2020

Conditions

Coronavirus InfectionIntensive Care Patients

Keywords

QT interval, ventricular repolarization

Outcome Measures

Primary Outcomes (1)

  • Assessing the QT and QTc interval in patients admitted to intensive care units for COVID-19 infection

    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.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • incidence of arrhythmias and impact of the COVI-drugs administered on QT interval

    through study completion, an average of 1 year

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients in critical care unit without COVID-19 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Anestesia, Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29898002RESULT

  • 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.

    PMID: 21040827RESULT

  • 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.

    PMID: 15203254RESULT

  • 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.

    PMID: 32031570RESULT

  • 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.

    PMID: 32211816RESULT

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Javier Hortal, MD PhD

    Hospital Universitario Gregorio Marañon

    STUDY CHAIR

Central Study Contacts

Matilde Zaballos, MDPhD

CONTACT

0034657813987mati@plagaro.net

Javier Hortal, MD PhD

CONTACT

915868367javier.hortal@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
specialist physician at Anesthesiology Department

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

May 29, 2020

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-05

Locations

ES(1)