Sodium Chloride and Protein-Bound Toxin Removal in Hemodiafiltration

NCT01923961 | Completed Results

• 1 other identifier: KSSA0113
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

Maintenance hemodialysis or hemodiafiltration; >18 years; Stable condition

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Plasma Sodium Concentrations

  4 hours

• Hemocompatibility

  4 hours

Study Arms (3)

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.

Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: 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.

Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: Standard Predilution Hemodiafiltration

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.

Procedure: HDF NaCl; Procedure: Hemodialysis; Procedure: Standard Predilution Hemodiafiltration

Interventions

HDF NaCl PROCEDURE

Also known as: Hemodialysis, Standard Predilution Hemodiafiltration

HD, Then Standard Pre-HDF, Then HDF NaCl; HDF NaCl, Then HD, Then Standard Pre-HDF; Standard Pre-HDF, Then HDF NaCl, Then HD

Hemodialysis PROCEDURE

Also known as: Standard Predilution Hemodiafiltration, HDF NaCl

HD, Then Standard Pre-HDF, Then HDF NaCl; HDF NaCl, Then HD, Then Standard Pre-HDF; Standard Pre-HDF, Then HDF NaCl, Then HD

Standard Predilution Hemodiafiltration PROCEDURE

Also known as: HDF NaCl, Hemodialysis

HD, Then Standard Pre-HDF, Then HDF NaCl; HDF NaCl, Then HD, Then Standard Pre-HDF; Standard Pre-HDF, Then HDF NaCl, Then HD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End-stage renal disease
• Maintenance hemodialysis or hemodiafiltration for more than 3 months
• Stable clinical condition
• \> 18 years

You may not qualify if:

• Life expectancy less than 1 year
• Pregnancy
• Active infectious disease

Sponsors & Collaborators

• EXcorLab GmbH: lead

Study Sites (1)

Dialysis Center Elsenfeld

Elsenfeld, Bavaria, 63820, Germany

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Results Point of Contact

• Title: 'Dr. Horst-Dieter Lemke
• Organization: eXcorLab GmbH

horstdieter.lemke@excorlab.de

+49-6022-812647

Study Officials

• Detlef H Krieter, MD

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2013
• First Posted: August 16, 2013
• Study Start: August 1, 2013
• Primary Completion: March 30, 2015
• Study Completion: August 10, 2015
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Locations

DE (1)