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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDF NaCl | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Sodium Concentrations | Maximum arterial sodium concentrations | 4 hours |
| Hemocompatibility | Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Detlef H Krieter, MD | Wuerzburg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Center Elsenfeld | Elsenfeld | Bavaria | 63820 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | HDF NaCl Infusion, Then HD, Then Standard Pre-HDF | Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration. |
| FG001 | HD, Then Standard Pre-HDF, Then HDF NaCl Infusion | Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl. |
| FG002 | Standard Pre-HDF, Then HDF NaCl Infusion, Then HD | Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HDF NaCl, Then HD, Then Standard Pre-HDF | Participants first received hemodiafiltration with infusion of 5 M NaCl for 4 hours. After a washout period of 1 week, they then received 4 hours of bicarbonate hemodialysis. After another washout period of 1 week, they reveived 4 hours of standard predilution hemodiafiltration. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per protocol population | Posted | Mean | Standard Deviation | percentage of reduction | 4 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hemodiafiltration, NaCl Infusion | 5 M NaCl solution will be infused to increase the NaCl concentration in the infusion fluid during predilution hemodiafiltration. 5 M NaCl solution: Infusion of 5 M NaCl adjusted at target NaCl concentration in plasma. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 'Dr. Horst-Dieter Lemke | eXcorLab GmbH | +49-6022-812647 | horstdieter.lemke@excorlab.de |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| Hemodialysis | Procedure |
|
|
| Standard Predilution Hemodiafiltration | Procedure |
|
|
| 4 hours |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| HD, Then Standard Pre-HDF, Then HDF NaCl |
Participants first received bicarbonate hemodialysis for 4 hours. After a washout period of 1 week, they then received 4 hours of standard predilution hemodiafiltration. After another washout period of 1 week, they reveived 4 hours of hemodiafiltration with infusion of 5 M NaCl. |
| BG002 | Standard Pre-HDF, Then HDF NaCl, Then HD | Participants first received standard predilution hemodiafiltration for 4 hours. After a washout period of 1 week, they then received 4 hours of hemodiafiltration with infusion of 5 M NaCl. After another washout period of 1 week, they reveived 4 hours of bicarbonate hemodialysis. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sodium Chloride (NaCl) Infusion | Count of Participants | Participants |
|
| OG002 | Hemodiafiltration | Standard predilution Hemodiafiltration |
|
|
| Primary | 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 | Per protocol analysis | Posted | Mean | Standard Deviation | percentage of reduction | 4 hours |
|
|
|
| Secondary | Plasma Sodium Concentrations | Maximum arterial sodium concentrations | Per protocol analysis | Posted | Mean | Standard Deviation | mval/l | 4 hours |
|
|
|
| Secondary | Hemocompatibility | Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction. | Per protocol analysis | Posted | Mean | Standard Deviation | percentage of total hemoglobin | 4 hours |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Hemodialysis | Standard bicarbonate high-flux hemodialysis | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Hemodiafiltration | Standard predilution Hemodiafiltration | 0 | 8 | 0 | 8 | 0 | 8 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |