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

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ClinicalTrials.gov Identifier: NCT01924663
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Tanya Holt, University of Saskatchewan

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.

Condition or disease
Heart Failure Acute Kidney Injury

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.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.
Actual Study Start Date : September 2013
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care




Primary Outcome Measures :
  1. Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram. [ Time Frame: up to 7 days ]
  2. Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria. [ Time Frame: up to 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pediatric subjects admitted to the local hospital with a confirmed positive respiratory viral swab.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924663


Locations
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Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Tanya Holt, M.D. University of Saskatchewan
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Responsible Party: Tanya Holt, Principal Investigator, Director of Paediatric Critical Care, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01924663    
Other Study ID Numbers: MyDAKI-01
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Keywords provided by Tanya Holt, University of Saskatchewan:
Heart Failure
Acute Kidney Injury
Myocardial Dysfunction
Pediatric Critical Care
Pediatric Intensive Care Units
Respiratory Virus
Additional relevant MeSH terms:
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Acute Kidney Injury
Heart Failure
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases