HemodialysisNCT03471299
Association of Survival in Impact of Ultrafiltration Rates in Hemodialysis Patients
An observational study of Hemodialysis, run by University of Hyogo at 1 site in Japan.
Trial summary
This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- How many people
- 759 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2017to 1 Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In this study, 759 patients who had undergone maintenance HD for >1 year at Tojinkai Hospital, kyoto, Japan. The present study examined data from all individual with regular thrice weekly maintenance HD treatment.
Who may be able to join
- Patients with stable undergoing hemodialysis for >1 year.
Who cannot join
- Patients with combined therapy with peritoneal dialysis and HD. Patients without records of laboratory investigations during this period. Patients with transferred hospital and those lost to follow-up.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Graduate School of Applied Informatics, University of Hyogo
Kobe, Hyōgo, 650-0047
About this study
Official title: Impact of Ultrafiltration Rates on Mortality in Maintenance Hemodialysis Patients
This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.
- Conditions
- Hemodialysis
- Keywords
- Ultrafiltration rate
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrafiltration rate (ml/hr/kg)
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Apr 2017
- Primary completion1 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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
- Retrospective
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hyogo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiro Tsuji, University of Hyogo
- Investigators
- Yuko Mizuno-Matsumoto, Ph.D, Study director, Graduate School of Applied Informatics, University of Hyogo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471299
- Sponsor's protocol ID
- Uhyogo3
- Status last verified
- Mar 2018
- First submitted
- 13 Mar 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrafiltration Rates on Mortality in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03471299
- Acronym / sponsor ID
- Uhyogo3
- Conditions
- Hemodialysis
- Keywords
- Ultrafiltration rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- University of HyogoUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 20 Mar 2018 (actual)
- 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.
This study assesses retrospectively the association of mortality on UFR assessments in our study population undergoing HD.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this study, 759 patients who had undergone maintenance HD for >1 year at Tojinkai Hospital, kyoto, Japan. The present study examined data from all individual with regular thrice weekly maintenance HD treatment.
Key inclusion criteria (1 listed)
- Patients with stable undergoing hemodialysis for >1 year.
Key exclusion criteria (1 listed)
- Patients with combined therapy with peritoneal dialysis and HD. Patients without records of laboratory investigations during this period. Patients with transferred hospital and those lost to follow-up.
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
Ultrafiltration rate (ml/hr/kg)
Time frame: 7 years
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 20 Mar 2018.
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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.
Yuko Mizuno-Matsumoto, Ph.D study director
Graduate School of Applied Informatics, University of Hyogo
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 Hemodialysis, run by University of Hyogo at 1 site in Japan.
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 1 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 20 Mar 2018. 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 Japan. 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?
Ultrafiltration rate (ml/hr/kg) (time frame: 7 years). 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 20 Mar 2018.