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

Heart Failure Clinical Trial

— MyDAKI-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924663
• Other study ID #: MyDAKI-01
• Status: Completed
• Start date: September 2013
• Est. completion date: December 2018

Study information

• Verified date: June 2020
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Failure
• Wounds and Injuries

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

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