Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF

NCT03288922 | Completed

• 1 other identifier: 291/58
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance protein-bound toxin and middle molecular toxin removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. This randomized crossover study was conducted to compare these uremic toxin removals between the new modality (limited BF OL-HDF with super high-flux dialyzer) and the control (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.

Conditions

End-stage Renal Disease; Hemodialysis

Keywords

Online Hemodiafiltration; Super high-flux dialyzer; Protein-bound uremic toxin; P-cresol

Outcome Measures

Primary Outcomes (1)

• pCS percentage of reduction ratio

  Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session of each modality. pCS levels were measured by high-performance liquid chromatography (HPLC). The percentage of reduction ratio were calculated from the before and ending samples.

  At time 0-hour and 4-hour of the study online hemodiafiltration session

Secondary Outcomes (3)

• IDS percentage of reduction ratio

  At time 0-hour and 4-hour of the study online hemodiafiltration session

• Beta2-microglobulin percentage of reduction ratio

  At time 0-hour and 4-hour of the study online hemodiafiltration session

• Albumin loss in spent dialysate

  During 4 hours of online hemodiafiltration session

Study Arms (2)

Limited BF OL-HDF with SHF

EXPERIMENTAL

Limited blood flow pre-dilution online hemodiafiltration using super high-flux dialyzer which had larger pore size than standard high-flux dialyzer was assigned as the new intervention to compare the efficacy of protein-bound toxin removals with the control period.

Procedure: Limited BF OL-HDF with SHF

High-efficiency OL-HDF

ACTIVE COMPARATOR

High-efficiency post-dilution online hemodiafiltration using standard high-flux dialyzer was assigned as the control period.

Procedure: High-efficiency OL-HDF

Interventions

Limited BF OL-HDF with SHF PROCEDURE

The new modality "Limited BF OL-HDF with SHF" were performed using Fresenius 5008 hemodiafiltration machine. The prescribed blood flow rate was 300 ml/min and the total dialysis fluid flow rate was 800 ml/min which included pre-filter substitution rate of 150 ml/min. The super high-flux dialyzer was PES-17Dα from Nipro Corporation, Japan which contains 1.7 m2 hollow fiber polyethersulfone membrane (ultrafiltration coefficient 80 ml/h/mmHg; urea clearance 267 ml/min, Qb 300 ml/min and Qd 500ml/min). The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm.

Limited BF OL-HDF with SHF

High-efficiency OL-HDF PROCEDURE

The controlled modality "High-efficiency OL-HDF" were performed using Fresenius 5008 hemodiafiltration machine. The prescribed blood flow rate was 400 ml/min and the total dialysis fluid flow rate was 800 ml/min which included post-filter substitution rate of 100 ml/min. The standard high-flux dialyzer that was used was HF80s from Fresenius Medical Care, Germany contains 1.8 m2 hollow fiber polysulfone membrane (ultrafiltration coefficient 55 ml/h/mmHg; urea clearance 248 ml/min, Qb 300ml/min and Qd 500 ml/min). The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm.

High-efficiency OL-HDF

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 patients treated with thrice-a-week OL-HDF for at least 6 months
• Residual urine \< 100 mL/day

You may not qualify if:

• Active cardiovascular disease
• Active malignancy
• Pregnancy
• Breast-feeding

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

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

Study Officials

• Khajohn Tiranathanagul, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Wanjak Pongsittisak

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

TH (1)