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

Not Applicable

Completed

• Conditions: End-stage Renal Disease; Hemodialysis
• Interventions: Procedure: Limited BF OL-HDF with SHF; Procedure: High-efficiency OL-HDF

• Registration Number: NCT03288922
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Elevated protein-bound toxins including p-cresol (pCS) and indoxyl sulfate (IDS) as well as middle-molecular toxins such as beta2-microglobulin (B2M) which could not be removed by hemodialysis (HD) are obviously correlated with high mortality. 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 pCS, IDS, and B2M removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. We innovated the OL-HDF modality for this limited BF situation by integrating the novel super high-flux membrane dialyzer (SHF; PES-17Dα, Nipro Corporation, Japan) into pre-dilution OL-HDF. This randomized crossover study was conducted to compare the uremic toxin removals between the new modality (limited BF OL-HDF with SHF) 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. Removals of pCS and IDS as well as small and middle molecule toxins were compared. The pCS and IDS were measured by high performance liquid chromatography. The dialysate albumin loss and patient safety were also monitored.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Primary Completion: 2017-10
• Status Verified: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Limited BF OL-HDF with SHF	Limited BF OL-HDF with SHF	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.
High-efficiency OL-HDF	High-efficiency OL-HDF	High-efficiency post-dilution online hemodiafiltration using standard high-flux dialyzer was assigned as the control period.

Primary Outcome Measures

Name	Time	Method
pCS percentage of reduction ratio	At time 0-hour and 4-hour of the study online hemodiafiltration session	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.

Secondary Outcome Measures

Name	Time	Method
Beta2-microglobulin percentage of reduction ratio	At time 0-hour and 4-hour of the study online hemodiafiltration session	Blood samples were taken from patients before and at the end of 4-hour in the first dialysis session of each modality. The percentage of reduction ratio were calculated from the before and ending samples.
Albumin loss in spent dialysate	During 4 hours of online hemodiafiltration session	Continuous sampling of spent effluent dialysate and ultrafiltrate were carried out with a collection pump inserted into the effluent outlet line via a special connector for total albumin loss determination.
IDS percentage of reduction ratio	At time 0-hour and 4-hour of the study online hemodiafiltration session	Blood samples were taken from patients before and at the end of 4-hour in the first session of each modality. IDS levels were measured by high-performance liquid chromatography (HPLC). The percentage of reduction ratio were calculated from the before and ending samples.

Trial Locations

Locations (1)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand