Clinical trial NCT03288922: Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF
Official title: Comparison of Protein-bound Toxins Removals Between Limited Blood Flow Online Hemodiafiltration Using Super High-flux Dialyzer and High-Efficiency Online Hemodiafiltration With High-flux Dialyzer: An Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Hemodialysis
Keywords: Online Hemodiafiltration
Super high-flux dialyzer
Protein-bound uremic toxin
P-cresol
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pCS percentage of reduction ratio
timeFrame: At time 0-hour and 4-hour of the study online hemodiafiltration session
Secondary outcomes:
measure: IDS percentage of reduction ratio
timeFrame: At time 0-hour and 4-hour of the study online hemodiafiltration session
measure: Beta2-microglobulin percentage of reduction ratio
timeFrame: At time 0-hour and 4-hour of the study online hemodiafiltration session
measure: Albumin loss in spent dialysate
timeFrame: During 4 hours of online hemodiafiltration session
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Chulalongkorn University
name: Khajohn Tiranathanagul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Wanjak Pongsittisak
role: PRINCIPAL_INVESTIGATOR
References: