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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01924663

Acronym

MyDAKI-01

Enrollment

Registered

2013-08-16

Start date

2013-09-30

Completion date

2018-12-31

Last updated

2020-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Heart Failure

Keywords

Heart Failure, Acute Kidney Injury, Myocardial Dysfunction, Pediatric Critical Care, Pediatric Intensive Care Units, Respiratory Virus

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

1. The parent or legal guardian of the pediatric subject must sign the Consent Form for participants in the prospective portion of the study. 2. The subject must be no greater than 18 years of age, at the time of consent. 3. The subject must be admitted to the local hospital. 4. The subject must have a confirmed positive respiratory viral swab.

Exclusion criteria

1. 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. 2. The subject has had previous kidney injury or myocardial dysfunction prior to positive respiratory viral swab. 3. 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.

Design outcomes

Primary

Measure	Time frame
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.	up to 7 days
Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.	up to 7 days

Countries

Canada

Outcome results