HaemodialysisQT_DIALNCT02887742
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
An observational study of Haemodialysis, run by University Hospital, Brest at 2 sites in France.
Trial summary
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis
- How many people
- 57 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2010to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Haemodialysed patients from two nephrology centers.
Who may be able to join
- >18
- patient under haemodialysis treatment
- patient not objecting to study
Who cannot join
- Patient with known cardiac arrythmias
Trial locations and contacts
2 sites in 1 country.
About this study
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
- Conditions
- Haemodialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of all the cardiologic abnormalities
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startOct 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Le meur, MD PhD, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887742
- Sponsor's protocol ID
- QT-DIAL (10.014)
- Acronym
- QT_DIAL
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
- ClinicalTrials.gov ID
- NCT02887742
- Acronym / sponsor ID
- QT_DIAL / QT-DIAL (10.014)
- Conditions
- Haemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Sep 2016 (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.
Epidemiologic Study and Impact Study of a Dialysis Solution Change on the Electrocardiographic Profile of Patient
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Haemodialysed patients from two nephrology centers.
Key inclusion criteria (3 listed)
- >18
- patient under haemodialysis treatment
- patient not objecting to study
Key exclusion criteria (1 listed)
- Patient with known cardiac arrythmias
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
Description of all the cardiologic abnormalities
Time frame: 3 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 10 Jan 2017.
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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.
Yannick Le meur, MD PhD study director
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis, run by University Hospital, Brest at 2 sites in France.
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 3 inclusion and 1 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 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Description of all the cardiologic abnormalities (time frame: 3 days). 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 10 Jan 2017.