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

NCT ID: NCT01924663

Last Updated: 2020-06-17

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

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure Acute Kidney Injury

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Tanya Holt

Principal Investigator, Director of Paediatric Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanya Holt, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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MyDAKI-01

Identifier Type: -

Identifier Source: org_study_id

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