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Completed

NCT Number: NCT01924663

Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury

The purpose of this study is to be able to better describe the incidence, timing and severity of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric patients.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

About this study

This is a single-centre, prospective and retrospective, descriptive data-collection pilot study.

Prospective Data Collection:

All pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab will be invited to participate.

Retrospective Data Collection:

The retrospective portion of this study will examine a 5 year period prior to the start of enrollment for the prospective study, with the intention to include all pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab and admitted into the local hospital's PICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The parent or legal guardian of the pediatric subject must sign the Consent Form for participants in the prospective portion of the study.
  • The subject must be no greater than 18 years of age, at the time of consent.
  • The subject must be admitted to the local hospital.
  • The subject must have a confirmed positive respiratory viral swab.

Exclusion criteria

  • The parent or legal guardian of the pediatric subject is unavailable or unwilling to sign the Consent Form for participants in the prospective portion of the study.
  • The subject has had previous kidney injury or myocardial dysfunction prior to positive respiratory viral swab.
  • The subject has any previous problems (prior to positive respiratory viral swab) with their heart or kidneys that could compromise the results, in the opinion of the Investigator.

Treatment and study plan

Primary outcomes

  1. Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.

    Time frame: up to 7 days

  2. Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.

    Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.

Acronym: MyDAKI-01

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2013
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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