Heart FailureMyDAKI-01NCT01924663
Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury
An observational study of Heart Failure and Acute Kidney Injury, run by University of Saskatchewan at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Failure, Acute Kidney Injury
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric subjects admitted to the local hospital with a confirmed positive respiratory viral swab.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Acute Kidney Injury
- Keywords
- Heart Failure, Acute Kidney Injury, Myocardial Dysfunction, Pediatric Critical Care, Pediatric Intensive Care Units, Respiratory Virus
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.
Measured: up to 7 days
Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Holt, University of Saskatchewan
- Investigators
- Tanya Holt, M.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924663
- Sponsor's protocol ID
- MyDAKI-01
- Acronym
- MyDAKI-01
- Status last verified
- Jun 2020
- First submitted
- 14 Aug 2013
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Illness in the Pediatric Critical Care Setting: the Incidence, Timing and Severity of Associated Myocardial Dysfunction and Acute Kidney Injury.
- ClinicalTrials.gov ID
- NCT01924663
- Acronym / sponsor ID
- MyDAKI-01 / MyDAKI-01
- Conditions
- Heart Failure, Acute Kidney Injury
- Keywords
- Heart Failure, Acute Kidney Injury, Myocardial Dysfunction, Pediatric Critical Care, Pediatric Intensive Care Units, Respiratory Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric subjects admitted to the local hospital with a confirmed positive respiratory viral swab.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram.
Time frame: up to 7 days
Acute Kidney Injury (AKI) as defined by the meeting of the pediatric RIFLE criteria.
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Holt, M.D. principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Acute Kidney Injury, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial dysfunction, as defined by a low ejection fraction on an Echocardiogram. (time frame: up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.