Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration

NCT ID: NCT01923961

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-08-10

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDF NaCl, Then HD, Then Standard Pre-HDF

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.

Group Type: EXPERIMENTAL

HDF NaCl

Intervention Type: PROCEDURE

Hemodialysis

Intervention Type: PROCEDURE

Standard Predilution Hemodiafiltration

Intervention Type: PROCEDURE

HD, Then Standard Pre-HDF, Then HDF NaCl

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.

Group Type: EXPERIMENTAL

HDF NaCl

Intervention Type: PROCEDURE

Hemodialysis

Intervention Type: PROCEDURE

Standard Predilution Hemodiafiltration

Intervention Type: PROCEDURE

Standard Pre-HDF, Then HDF NaCl, Then HD

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.

Group Type: EXPERIMENTAL

HDF NaCl

Intervention Type: PROCEDURE

Hemodialysis

Intervention Type: PROCEDURE

Standard Predilution Hemodiafiltration

Intervention Type: PROCEDURE

Interventions

HDF NaCl

Intervention Type: PROCEDURE

Hemodialysis

Intervention Type: PROCEDURE

Standard Predilution Hemodiafiltration

Intervention Type: PROCEDURE

Other Intervention Names

Hemodialysis; Standard Predilution Hemodiafiltration; Standard Predilution Hemodiafiltration; HDF NaCl; HDF NaCl; Hemodialysis

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EXcorLab GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Detlef H Krieter, MD

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital

Locations

Dialysis Center Elsenfeld

Elsenfeld, Bavaria, Germany

Countries

Germany

Other Identifiers

KSSA0113

Identifier Type: -

Identifier Source: org_study_id