Effects of Convective Therapies in Dialysis Patients

Study Overview
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Brief Summary
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Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension. To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.

Official Title
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Effects of Convective Therapies in Dialysis Patients

Conditions
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Uremia

Intervention / Treatment
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* Procedure: online pre-dilution hemofiltration
* Procedure: online pre-dilution hemodiafiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dialysis patients aged 18-80 years thrice-weekly HD or HDF for at least 6 months body weight less or equal to 90 Kg stable clinical condition written consent Exclusion Criteria: infections malignancies active systemic diseases active hepatitis or cirrhosis unstable diabetes diuresis higher than 200 ml/24h dysfunction of vascular access blood flow rate less than 300 ml/min

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: low-flux hemodialysis<br> | |
| Experimental: online pre-dilution hemofiltration<br> | Procedure: online pre-dilution hemofiltration<br>* Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one<br>* Other names: online pre-dilution hemofiltration Technique;|
| Experimental: online pre-dilution hemodiafiltration<br> | Procedure: online pre-dilution hemodiafiltration<br>* Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.<br>* Other names: online pre-dilution hemodiafiltration Technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intradialytic symptomatic hypotension | Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention | all dialysis sessions, three per week, for 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance to erythropoiesis-stimulating agents | Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg) | Monthly for 2 years | 
| Calcium-phosphate metabolism | Outcome measures: phosphatemia, calcemia and PTH | Monthly for 2 years | 
| Beta2 microglobulin |  | Every six months for 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration