End-stage Renal DiseaseNCT02576873
Long-term Outcome of End-stage Renal Disease Patients Treated With Hig-efficiency Hemodiafiltration
An observational study of End-stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital between 2001-2013 to determine the survival rate as well as other long-term outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Hemodiafiltration
- How many people
- 66 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2014to Mar 2016
- 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: End-stage renal disease patients who had been received long-term hemodiafiltration at King Chulalongkorn Memorial hospital during 2001-2013
Who may be able to join
- Aged 18 years or more
- Be diagnosed end-stage renal disease for more than one year
- Have been regularly received long-term hemodiafiltration for more than 6 months.
Who cannot join
- Patients who received hemodiafiltration less than 6 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Pathumwan, Bangkok, 10330
About this study
Official title: Long-term Outcome of End-stage Renal Disease Patients Treated With High-efficiency Hemodiafiltration: a Historical Cohort of a Single-center in South East Asia
A retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital between 2001-2013 to determine the survival rate as well as other long-term outcome.
Read the detailed description
Growing evidences suggested the superiority of high-efficiency hemodiafiltration (HDF) which could provide both diffusion and convection in a single therapy compared with the conventional hemodialysis. However, the long-term, upto 10 years, outcome still limited. This retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in a single-center, King Chulalongkorn Memorial Hospital, between 2001-2013 to determine the survival rate as well as other long-term outcome
- Conditions
- End-stage Renal Disease
- Being tested
- Hemodiafiltration
- Keywords
- Survival, Hemodiafiltration, End-stage renal disease, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodiafiltrationOther
Hemodiafiltration treatments were prescribed to the patients as their long-term renal replacement therapies
| Study group | Role | What they receive |
|---|---|---|
| Hemodiafiltration | End-stage renal disease patients who were treated with high-efficiency hemodiafiltration for more than 6 months Receives: Other: Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The Kaplan-Meier survival curve and mean survival time will be demonstrated for primary outcome.
Measured: 10 years
Secondary outcomes (2)
Comparison of survival differences between patients who start renal replacement therapy with HDF and who switched from hemodialysis as well as between diabetic and non-diabetic patient.
Survival differences between groups will be evaluated with the Kaplan-Meier method and compared using the log-rank test. The comparative groups include:
- Patient who start renal replacement therapy with HDF (incident cases) vs. who switched from hemodialysis (prevalence cases)
- Diabetic vs. Non-diabetic patients
Measured: 10 years
Factors that associated with all-cause mortality
univariate and multivariate analysis the factors that might affected the long-term outcomes. The factors include dialytic parameters (spKt/Vurea, TAC urea), nutritional parameters (nPNA, albumin), inflammatory parameter (hsCRP), and biochemical parameters (BUN, Cr, Ca, Phosphate, iPTH, beta2-microglobulin, Hb, Ferritin, Transferrin saturation, Cholesterol, Triglyceride, HDL, and LDL)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startMar 2014
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khajohn Tiranathanagul, Chulalongkorn University
- Investigators
- Khajohn Tiranathanagul, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576873
- Sponsor's protocol ID
- 455/56
- Status last verified
- Jul 2016
- First submitted
- 13 Oct 2015
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of End-stage Renal Disease Patients Treated With High-efficiency Hemodiafiltration: a Historical Cohort of a Single-center in South East Asia
- ClinicalTrials.gov ID
- NCT02576873
- Acronym / sponsor ID
- 455/56
- Conditions
- End-stage Renal Disease
- Keywords
- Survival, Hemodiafiltration, End-stage renal disease, Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Oct 2015 (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.
A retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in King Chulalongkorn Memorial Hospital between 2001-2013 to determine the survival rate as well as other long-term outcome.
Detailed description
Growing evidences suggested the superiority of high-efficiency hemodiafiltration (HDF) which could provide both diffusion and convection in a single therapy compared with the conventional hemodialysis. However, the long-term, upto 10 years, outcome still limited. This retrospective cohort study was conducted in 66 end-stage renal disease patients who underwent high-efficiency hemodiafiltration technique in a single-center, King Chulalongkorn Memorial Hospital, between 2001-2013 to determine the survival rate as well as other long-term outcome
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodiafiltration | – | Other: HemodiafiltrationEnd-stage renal disease patients who were treated with high-efficiency hemodiafiltration for more than 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients who had been received long-term hemodiafiltration at King Chulalongkorn Memorial hospital during 2001-2013
Key inclusion criteria (3 listed)
- Aged 18 years or more
- Be diagnosed end-stage renal disease for more than one year
- Have been regularly received long-term hemodiafiltration for more than 6 months.
Key exclusion criteria (1 listed)
- Patients who received hemodiafiltration less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemodiafiltrationHemodiafiltration treatments were prescribed to the patients as their long-term renal replacement therapies | Other | Hemodiafiltration |
Primary outcome
Survival rate
Time frame: 10 years
The Kaplan-Meier survival curve and mean survival time will be demonstrated for primary outcome.
2 secondary outcomes
Comparison of survival differences between patients who start renal replacement therapy with HDF and who switched from hemodialysis as well as between diabetic and non-diabetic patient.
Time frame: 10 years
Factors that associated with all-cause mortality
Time frame: 10 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 28 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Khajohn Tiranathanagul, MD principal investigator
Chulalongkorn University
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 End-stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
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 28 Jul 2016. 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 Thailand. 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?
Survival rate (time frame: 10 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 28 Jul 2016.