An interventional study of HDF NaCl and Hemodialysis in End-stage Renal Disease, sponsored by EXcorLab GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by EXcorLab GmbH · Not applicable, Interventional, and Treatment
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.
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 8 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →EXcorLab GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: HDF NaCl · Procedure: Hemodialysis · Procedure: Standard Predilution Hemodiafiltration
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.
Procedure: HDF NaCl · Procedure: Hemodialysis · Procedure: Standard Predilution Hemodiafiltration
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.
Procedure: HDF NaCl · Procedure: Hemodialysis · Procedure: Standard Predilution Hemodiafiltration
Also known as: Hemodialysis, Standard Predilution Hemodiafiltration
Also known as: Standard Predilution Hemodiafiltration, HDF NaCl
Also known as: HDF NaCl, Hemodialysis
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
Time frame: 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
Time frame: 4 hours
Plasma Sodium Concentrations
Maximum arterial sodium concentrations
Time frame: 4 hours
Hemocompatibility
Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.
Time frame: 4 hours
| Milestone | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 3 | 2 |
| Not completed | 0 | 0 | 0 |
| Milestone | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 3 | 2 |
| Not completed | 0 | 0 | 0 |
| Milestone | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 3 | 2 |
| Not completed | 0 | 0 | 0 |
| Milestone | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 3 | 2 |
| Not completed | 0 | 0 | 0 |
| Milestone | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD |
|---|---|---|---|
| Started | 3 | 3 | 2 |
| Completed | 3 | 3 | 2 |
| Not completed | 0 | 0 | 0 |
Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
| percentage of reduction | Hemodiafiltration, NaCl Infusion | Hemodialysis | Hemodiafiltration |
|---|---|---|---|
| Removal of Para-cresylsulfate | 42.0 ± 22.1 | 32.6 ± 18.5 | 33.6 ± 16.1 |
Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention
| percentage of reduction | Hemodiafiltration, NaCl Infusion | Hemodialysis | Hemodiafiltration |
|---|---|---|---|
| Removal of Indoxylsulfate | 34.8 ± 23.5 | 26.5 ± 18.1 | 30.9 ± 23.9 |
Maximum arterial sodium concentrations
| mval/l | Hemodiafiltration, NaCl Infusion | Hemodialysis | Hemodiafiltration |
|---|---|---|---|
| Plasma Sodium Concentrations | 136 ± 3 | 133 ± 2 | 134 ± 2 |
Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.
| percentage of total hemoglobin | Hemodiafiltration, NaCl Infusion | Hemodialysis | Hemodiafiltration |
|---|---|---|---|
| Hemocompatibility | 0.09 ± 0.04 | 0.07 ± 0.03 | 0.08 ± 0.02 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hemodiafiltration, NaCl Infusion | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Hemodialysis | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Hemodiafiltration | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 2 | 1 | 5 |
| >=65 years | 1 | 1 | 1 | 3 |
| Age, Continuous(years) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| Median | 62 (46 to 78) | 62 (46 to 78) | 62 (46 to 78) | 62 (46 to 78) |
| Sex: Female, Male(Participants) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| Female | 2 | 1 | 1 | 4 |
| Male | 1 | 2 | 1 | 4 |
| Race (NIH/OMB)(Participants) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 3 | 3 | 2 | 8 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| Germany | 3 | 3 | 2 | 8 |
| Sodium Chloride (NaCl) Infusion(Participants) | HDF NaCl, Then HD, Then Standard Pre-HDF | HD, Then Standard Pre-HDF, Then HDF NaCl | Standard Pre-HDF, Then HDF NaCl, Then HD | Total |
|---|---|---|---|---|
| Count of participants | 3 | 3 | 2 | 8 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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