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

Completed

• Conditions: Acute Kidney Injury; Heart Failure

• Registration Number: NCT01924663
• Lead Sponsor: University of Saskatchewan

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.

Study Timeline

• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-16
• Study Start: 2013-09
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada