Skip to main content
Clinical Trials/NCT01924663
NCT01924663CompletedNot Applicable

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

University of Saskatchewan1 site in 1 country21 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Other

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Time Frame: up to 7 days

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

Time Frame: up to 7 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tanya Holt

Principal Investigator, Director of Paediatric Critical Care

University of Saskatchewan

Study Sites (1)

Loading locations...

Similar Trials