HemodiafiltrationNCT03288285
Comparison of Post- and Pre-dilutional Hemodiafiltration in Hemodialysis Patients
An observational study of Hemodiafiltration, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
Trial summary
Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large and middle molecule uremic toxins comparing to conventional hemodialysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hemodiafiltration
- How many people
- 49 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 7 Apr 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodialysis (HD) patients
Who may be able to join
- stable patients end-stage renal disease who were older than 20 years and received thrice-weekly standard hemodialysis for more than 3 months were recruited.
Who cannot join
- active systemic disease, liver cirrhosis, malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (kt/V<1.2).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Post- and Pre-dilutional Hemodiafiltration on Patients With End-stage Renal Disease
Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of hemodiafiltration include pre-dilution and post-dilution according to the infusion site of substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of uremic toxins. However, hemoconcentration and clotting of membrane limit its further clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic status. Although lower clearance of small molecule uremic toxins, one study in Japan showed survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological parameters and clearance of uremic toxins by using cross-over study design.
Read the detailed description
- Study design: randomly assigned, cross-over study.
- Patient number: 60.
- Inclusion criteria: stable patients end-stage renal disease who were older than 20 years and received thrice-weekly standard hemodialysis for more than 3 months were recruited.
- Exclusion criteria: active systemic disease, liver cirrhosis, active malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (single-pooled Kt/V<1.2).
- Methods: Prior to randomization, a Charlson Comorbidity Index score and baseline characteristics are recorded for each patient. Each patient who received HDF prior to study will received one-month high-flux hemodialysis with target single-pooled Kt/V>1.2 for washout. The baseline characteristics of each patient including dialyzer, dialysis time, blood flow, dialysate flow, replacement volume, pre- and post-dialysis blood pressure and body weight were recorded. The follow-up laboratory data will also be collected: predialysis C-reactive protein, blood urea nitrogen, creatinine, bicarbonate, sodium, potassium, uric acid, albumin, calcium, phosphate, intact parathyroid hormone, β2-microglobulin, prolactin, fibroblast growth factor 23, α1-microglobulin, indoxyl sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis factor-α, hematocrit, transferrin saturation and ferritin. Urea kinetics including kt/V, Urea reduction ratio and normalized protein catabolic rate are calculated. We also used Physical Symptoms Distress Scale for life quality measurement. After randomization, two group received standard prescription of pre- and post-dilution HDF. The prescribed convective volume per treatment of post-dilution mode is based on blood flow, filtration fraction and hematocrit to achieved current recommendation of 23 liter/1.73m2. The convective volume of pre-dilution mode will be at least twice higher than the desired dose in post-dilution mode for each patient. After 3-month stable hemodiafiltration, parameters mentioned above will also be checked. Two group will be switched for another 3-month course and then switch again. The total following time is 12 months.
- Outcome: The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules. Secondary outcomes are intradialytic tolerance, including intradialytic hypotension, cramps and arrhythmia, and life quality measurements.
- Conditions
- Hemodiafiltration
- Keywords
- hemodiafiltration, pre-dilution, post-dilution, uremic toxins
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of a wide spectrum of solutes
The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules
Measured: 1 years
Secondary outcomes (1)
Intradialytic tolerance
intradialytic tolerance including symptomatic hypotension, cramps, headache, nutrition, and inflammatory status.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Oct 2018
- Study completion7 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodiafiltrationStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chang-Hsu Chen, MD, Principal investigator, Tungs' Taichung Metroharbour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03288285
- Sponsor's protocol ID
- 106042
- Status last verified
- Apr 2019
- First submitted
- 15 Sep 2017
- Last updated
- 23 Apr 2019
- 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 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Post- and Pre-dilutional Hemodiafiltration on Patients With End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT03288285
- Acronym / sponsor ID
- 106042
- Conditions
- Hemodiafiltration
- Keywords
- hemodiafiltration, pre-dilution, post-dilution, uremic toxins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 7 Apr 2019 (actual)
- First posted
- 20 Sep 2017 (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.
Hemodiafiltration (HDF) is a choice of treatment modalities for patients with end-stage renal disease. Hemodiafiltration, combining diffusion and convection, may increase removal of large and middle molecule uremic toxins comparing to conventional hemodialysis. The techniques of hemodiafiltration include pre-dilution and post-dilution according to the infusion site of substitution fluid. Post-dilution HDF is most widely used because of higher removal rate of uremic toxins. However, hemoconcentration and clotting of membrane limit its further clearance of toxins. Pre-dilution may preserve membrane permeability and maintain hemodynamic status. Although lower clearance of small molecule uremic toxins, one study in Japan showed survival benefits of pre-dilution HDF, comparing to post-dilution HDF. The aim of this study was to compare pre-dilution and post-dilution HDF in terms of their clinical and biological parameters and clearance of uremic toxins by using cross-over study design.
Detailed description
- Study design: randomly assigned, cross-over study.
- Patient number: 60.
- Inclusion criteria: stable patients end-stage renal disease who were older than 20 years and received thrice-weekly standard hemodialysis for more than 3 months were recruited.
- Exclusion criteria: active systemic disease, liver cirrhosis, active malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (single-pooled Kt/V<1.2).
- Methods: Prior to randomization, a Charlson Comorbidity Index score and baseline characteristics are recorded for each patient. Each patient who received HDF prior to study will received one-month high-flux hemodialysis with target single-pooled Kt/V>1.2 for washout. The baseline characteristics of each patient including dialyzer, dialysis time, blood flow, dialysate flow, replacement volume, pre- and post-dialysis blood pressure and body weight were recorded. The follow-up laboratory data will also be collected: predialysis C-reactive protein, blood urea nitrogen, creatinine, bicarbonate, sodium, potassium, uric acid, albumin, calcium, phosphate, intact parathyroid hormone, β2-microglobulin, prolactin, fibroblast growth factor 23, α1-microglobulin, indoxyl sulfate, p-cresol sulfate, advance oxidation protein products, advance glycation product, percentage of proinflammatory monocytes; interleukin-6, tumor necrosis factor-α, hematocrit, transferrin saturation and ferritin. Urea kinetics including kt/V, Urea reduction ratio and normalized protein catabolic rate are calculated. We also used Physical Symptoms Distress Scale for life quality measurement. After randomization, two group received standard prescription of pre- and post-dilution HDF. The prescribed convective volume per treatment of post-dilution mode is based on blood flow, filtration fraction and hematocrit to achieved current recommendation of 23 liter/1.73m2. The convective volume of pre-dilution mode will be at least twice higher than the desired dose in post-dilution mode for each patient. After 3-month stable hemodiafiltration, parameters mentioned above will also be checked. Two group will be switched for another 3-month course and then switch again. The total following time is 12 months.
- Outcome: The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules. Secondary outcomes are intradialytic tolerance, including intradialytic hypotension, cramps and arrhythmia, and life quality measurements.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis (HD) patients
Key inclusion criteria (1 listed)
- stable patients end-stage renal disease who were older than 20 years and received thrice-weekly standard hemodialysis for more than 3 months were recruited.
Key exclusion criteria (1 listed)
- active systemic disease, liver cirrhosis, malignancy, receiving immunosuppressive treatment, dialysis with temporal non-tunneled catheter, inadequate dialysis dose (kt/V<1.2).
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
Removal of a wide spectrum of solutes
Time frame: 1 years
The primary objective is to compare the removal of a wide spectrum of solutes such as middle and protein-bound molecules
1 secondary outcome
Intradialytic tolerance
Time frame: 1 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 23 Apr 2019.
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Clinical Characteristics and In-Hospital Outcomes of Critically Ill Patients Receiving Hemodialysis or Continuous Venovenous Hemodiafiltration in the Emergency Department
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Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance
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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.
Chang-Hsu Chen, MD principal investigator
Tungs' Taichung Metroharbour Hospital
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 Hemodiafiltration, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
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 23 Apr 2019. 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 Taiwan. 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?
Removal of a wide spectrum of solutes (time frame: 1 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 23 Apr 2019.