Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury (MyDAKI-01)

This study is currently recruiting participants.
Verified November 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01924663
First received: August 14, 2013
Last updated: February 4, 2014
Last verified: November 2013

August 14, 2013
February 4, 2014
September 2013
July 2015   (final data collection date for primary outcome measure)
  • Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram. [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
  • Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria. [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01924663 on ClinicalTrials.gov Archive Site
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Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury
Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.

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.

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.

Observational
Observational Model: Case-Only
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Probability Sample

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

  • Heart Failure
  • Acute Kidney Injury
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
  5. An arterial or venous line must be in place for blood draws for participants in the prospective portion of the study.

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.
Both
up to 18 Years
No
Contact: Tanya Holt, M.D. (306) 966-8125 tanya.holt@usask.ca
Canada
 
NCT01924663
MyDAKI-01
No
University of Saskatchewan
University of Saskatchewan
Not Provided
Principal Investigator: Tanya Holt, M.D. University of Saskatchewan
University of Saskatchewan
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP