Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration

End-stage Renal Disease Clinical Trial

Official title:

Impact of an Increased Sodium Chloride Concentration in the Infusion Fluid of Predilution Hemodiafiltration on the Removal of Protein-Bound Uremic Toxins

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01923961
• Other study ID #: KSSA0113
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: August 10, 2015

Study information

• Verified date: July 2018
• Source: EXcorLab GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 be determined. Comparisons will be made to standard hemodialysis and hemodiafiltration.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 10, 2015
• Est. primary completion date: March 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• End-stage renal disease

• Maintenance hemodialysis or hemodiafiltration for more than 3 months

• Stable clinical condition

• > 18 years

Exclusion Criteria:

• Life expectancy less than 1 year

• Pregnancy

• Active infectious disease

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• HDF NaCl

• Hemodialysis

• Standard Predilution Hemodiafiltration

Locations

Country	Name	City	State
Germany	Dialysis Center Elsenfeld	Elsenfeld	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
EXcorLab GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	4 hours
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	4 hours
Secondary	Plasma Sodium Concentrations	Maximum arterial sodium concentrations	4 hours
Secondary	Hemocompatibility	Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.	4 hours