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

NCT01924663 | Completed

• 1 other identifier: MyDAKI-01
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Acute Kidney Injury

Keywords

Heart Failure; Acute Kidney Injury; Myocardial Dysfunction; Pediatric Critical Care; Pediatric Intensive Care Units; Respiratory Virus

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pediatric subjects admitted to the local hospital with a confirmed positive respiratory viral swab.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Heart Failure; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tanya Holt, M.D.

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of Paediatric Critical Care

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

CA (1)