Clinical trial NCT01924663: Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury
Official title: Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Acute Kidney Injury
Keywords: Heart Failure
Acute Kidney Injury
Myocardial Dysfunction
Pediatric Critical Care
Pediatric Intensive Care Units
Respiratory Virus
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 21
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric subjects admitted to the local hospital with a confirmed positive respiratory viral swab.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.
timeFrame: up to 7 days
measure: Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Tanya Holt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: