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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Heart Failure
Acute Kidney Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924663

Contacts
Contact: Tanya Holt, M.D. (306) 966-8125 tanya.holt@usask.ca

Locations
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Principal Investigator: Tanya Holt, MD FRCPC         
Sub-Investigator: William Bingham, MD FRCPC         
Sub-Investigator: Ashok Kakadekar, MD FRCPC         
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Tanya Holt, M.D. University of Saskatchewan
  More Information

No publications provided

Responsible Party: University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01924663     History of Changes
Other Study ID Numbers: MyDAKI-01
Study First Received: August 14, 2013
Last Updated: February 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Heart Failure
Acute Kidney Injury
Myocardial Dysfunction
Pediatric Critical Care
Pediatric Intensive Care Units
Respiratory Virus

Additional relevant MeSH terms:
Acute Kidney Injury
Heart Failure
Virus Diseases
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014