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Completed

NCT Number: NCT01923961

Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDF NaCl

Procedure

Other names: Hemodialysis, Standard Predilution Hemodiafiltration

hemodialysis

Procedure

Other names: Standard Predilution Hemodiafiltration, HDF NaCl

Standard Predilution Hemodiafiltration

Procedure

Other names: HDF NaCl, Hemodialysis

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Plasma Sodium Concentrations

    Time frame: 4 hours

    Maximum arterial sodium concentrations

  2. Hemocompatibility

    Time frame: 4 hours

    Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.

Sponsors and collaborators

Lead sponsor

EXcorLab GmbH

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2013
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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