End-stage Renal DiseaseNCT01923961
Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration
A study testing HDF NaCl, Hemodialysis and Standard Predilution Hemodiafiltration in people with End-stage Renal Disease, run by EXcorLab GmbH at 1 site in Germany.
Trial summary
An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will… 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?
- HDF NaCl, Hemodialysis and Standard Predilution Hemodiafiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to 10 Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- End-stage renal disease
- Maintenance hemodialysis or hemodiafiltration for more than 3 months
- Stable clinical condition
- > 18 years
Who cannot join
- Life expectancy less than 1 year
- Pregnancy
- Active infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins
An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.
Read the detailed description
Eight maintenance dialysis patients will be enrolled in a prospective, randomized, crossover trial. HD will be compared with online pre-dilution HDF and HDF at increased plasma ionic strength. The ionic strength will be increased using an infusion fluid with hypertonic [Na+] by isovolumetric adding of a 5000 mmol/L NaCl solution. Blood and dialysate flowrates (250 and 575 mL/min, respectively), treatment time (240 min), and high-flux dialyser (surface area 2.1 sqm, PUREMA H) will be always kept identical. Anticoagulation with standard or fractionated heparin will be unchanged adopted from the patients' routinely used regimen. In both HDF modes, the infusion flow rate will be 125 mL/min. In HDF at increased plasma ionic strength, the infusate [Na+] will be adjusted to approach 240 mmol/L in plasma entering the dialyser and the dialysate [Na+] will be set at the technically feasible minimum of 130 mmol/L. Blood samples will be drawn from the arterial and venous blood lines and, if applicable, from the blood tubing connecting the two dialyzers at 0, 15, 30, 60, 120, 180, and 240 min. Samples at 240 min will be drawn after reducing the blood flow rate to 50 mL/min for 30 s and the dialysate flow turned off. A fraction of the spent dialysate will be continuously collected.
Removal of the free and total fraction of para-cresyl sulfate and indoxyl sulfate will be determined by reduction ratios, dialytic clearances and mass in dialysate
Hemocompatibility will be assessed by WBC and platelet counts, free Hb, LDH, C5a and TAT. [Na+] will be monitored in both arterial (i.e. before NaCl infusion) and venous blood of the extracorporeal system.
- Conditions
- End-stage Renal Disease
- Being tested
- HDF NaCl, Hemodialysis, Standard Predilution Hemodiafiltration
- Keywords
- Maintenance hemodialysis or hemodiafiltration, >18 years, Stable condition
- 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.
HDF NaClProcedure or surgery
Also called Hemodialysis, Standard Predilution Hemodiafiltration
HemodialysisProcedure or surgery
Also called Standard Predilution Hemodiafiltration, HDF NaCl
Standard Predilution HemodiafiltrationProcedure or surgery
Also called HDF NaCl, Hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| HDF NaCl, Then HD, Then Standard Pre-HDF | Experimental | Participants first receive hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then receive 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveive 4 hours of standard predilution hemodiafiltration. Receives: Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: Standard Predilution Hemodiafiltration |
| HD, Then Standard Pre-HDF, Then HDF NaCl | Experimental | Participants first receive bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then receive 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveive 4 hours of hemodiafiltration with infusion of 5 M NaCl. Receives: Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: Standard Predilution Hemodiafiltration |
| Standard Pre-HDF, Then HDF NaCl, Then HD | Experimental | Participants first receive standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then receive hemodiafiltration with infusion of 5 M NaCl 4 hours of. After another washout period of 1 week, they reveive 4 hours of bicarbonate hemodialysis. Receives: Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: Standard Predilution Hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal of Para-cresylsulfate
Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Measured: 4 hours
Removal of Indoxylsulfate
Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Measured: 4 hours
Secondary outcomes (2)
Plasma Sodium Concentrations
Maximum arterial sodium concentrations
Measured: 4 hours
Hemocompatibility
Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.
Measured: 4 hours
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 startAug 2013
- Primary completion30 Mar 2015
- Study completion10 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- EXcorLab GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Detlef H Krieter, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923961
- Sponsor's protocol ID
- KSSA0113
- Status last verified
- Jul 2018
- First submitted
- 10 Aug 2013
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins
- ClinicalTrials.gov ID
- NCT01923961
- Acronym / sponsor ID
- KSSA0113
- Conditions
- End-stage Renal Disease
- Keywords
- Maintenance hemodialysis or hemodiafiltration, >18 years, Stable condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- EXcorLab GmbHUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- 30 Mar 2015 (actual)
- Study completion
- 10 Aug 2015 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An increase of the free fraction may allow a better removal of of protein-bound uremic toxins during dialysis. During predilution hemodiafiltration, the sodium chloride (NaCl) concentration will be increased in the infusion fluid at a target NaCl concentration and the effect on the removal of protein-bound toxins will be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.
Detailed description
Eight maintenance dialysis patients will be enrolled in a prospective, randomized, crossover trial. HD will be compared with online pre-dilution HDF and HDF at increased plasma ionic strength. The ionic strength will be increased using an infusion fluid with hypertonic [Na+] by isovolumetric adding of a 5000 mmol/L NaCl solution. Blood and dialysate flowrates (250 and 575 mL/min, respectively), treatment time (240 min), and high-flux dialyser (surface area 2.1 sqm, PUREMA H) will be always kept identical. Anticoagulation with standard or fractionated heparin will be unchanged adopted from the patients' routinely used regimen. In both HDF modes, the infusion flow rate will be 125 mL/min. In HDF at increased plasma ionic strength, the infusate [Na+] will be adjusted to approach 240 mmol/L in plasma entering the dialyser and the dialysate [Na+] will be set at the technically feasible minimum of 130 mmol/L. Blood samples will be drawn from the arterial and venous blood lines and, if applicable, from the blood tubing connecting the two dialyzers at 0, 15, 30, 60, 120, 180, and 240 min. Samples at 240 min will be drawn after reducing the blood flow rate to 50 mL/min for 30 s and the dialysate flow turned off. A fraction of the spent dialysate will be continuously collected.
Removal of the free and total fraction of para-cresyl sulfate and indoxyl sulfate will be determined by reduction ratios, dialytic clearances and mass in dialysate
Hemocompatibility will be assessed by WBC and platelet counts, free Hb, LDH, C5a and TAT. [Na+] will be monitored in both arterial (i.e. before NaCl infusion) and venous blood of the extracorporeal system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDF NaCl, Then HD, Then Standard Pre-HDF | Experimental | Procedure: HDF NaCl, Procedure: Hemodialysis, Procedure: Standard Predilution HemodiafiltrationParticipants first receive hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then receive 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveive 4 hours of standard predilution hemodiafiltration. |
| HD, Then Standard Pre-HDF, Then HDF NaCl | Experimental | Procedure: HDF NaCl, Procedure: Hemodialysis, Procedure: Standard Predilution HemodiafiltrationParticipants first receive bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then receive 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveive 4 hours of hemodiafiltration with infusion of 5 M NaCl. |
| Standard Pre-HDF, Then HDF NaCl, Then HD | Experimental | Procedure: HDF NaCl, Procedure: Hemodialysis, Procedure: Standard Predilution HemodiafiltrationParticipants first receive standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then receive hemodiafiltration with infusion of 5 M NaCl 4 hours of. After another washout period of 1 week, they reveive 4 hours of bicarbonate hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End-stage renal disease
- Maintenance hemodialysis or hemodiafiltration for more than 3 months
- Stable clinical condition
- > 18 years
Key exclusion criteria (3 listed)
- Life expectancy less than 1 year
- Pregnancy
- Active infectious disease
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 |
|---|---|---|
| HDF NaClAlso: Hemodialysis, Standard Predilution Hemodiafiltration | Procedure or surgery | HD, Then Standard Pre-HDF, Then HDF NaCl, HDF NaCl, Then HD, Then Standard Pre-HDF, Standard Pre-HDF, Then HDF NaCl, Then HD |
| HemodialysisAlso: Standard Predilution Hemodiafiltration, HDF NaCl | Procedure or surgery | HD, Then Standard Pre-HDF, Then HDF NaCl, HDF NaCl, Then HD, Then Standard Pre-HDF, Standard Pre-HDF, Then HDF NaCl, Then HD |
| Standard Predilution HemodiafiltrationAlso: HDF NaCl, Hemodialysis | Procedure or surgery | HD, Then Standard Pre-HDF, Then HDF NaCl, HDF NaCl, Then HD, Then Standard Pre-HDF, Standard Pre-HDF, Then HDF NaCl, Then HD |
Primary outcome
Removal of Para-cresylsulfate
Time frame: 4 hours
Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
Removal of Indoxylsulfate
Time frame: 4 hours
Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
2 secondary outcomes
Plasma Sodium Concentrations
Time frame: 4 hours
Hemocompatibility
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Detlef H Krieter, MD principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HDF NaCl, Hemodialysis and Standard Predilution Hemodiafiltration in people with End-stage Renal Disease, run by EXcorLab GmbH at 1 site in Germany.
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 16 Jan 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 Germany. 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?
Yes. Results are posted in the registry (first posted 16 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Para-cresylsulfate (time frame: 4 hours). 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 16 Jan 2019.