Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

Study Overview
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Brief Summary
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HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.

Official Title
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Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: Daily hemodialysis at low dialysate flow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patients who give voluntary signed informed consent Patients affiliated with the French universal health care system or similar For women of childbearing potential: serum or urine negative pregnancy test Patients treated with conventional hemodialysis (3 times 4h to 5h per week at at least a dialysate flow rate of 500 ml/min) for at least 3 months and clinically stable (investigator assessment) Bipuncture patients (or with double lumen central venous catheter) with stable vascular access and easy to puncture Patients willing to be treated with daily hemodialysis at low dialysate flow during the study period (6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis) Exclusion Criteria: Pregnant women or women who could become pregnant during the study (planned pregnancy within 3 months) Patients not affiliated with the French universal health care system Minor patients Patients who are protected adults according to the terms of the law (French public health laws). Refusal to give consent Patients simultaneously participating in another trial that may interfere with the study results

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily hemodialysis at low dialysate flow<br> | Other: Daily hemodialysis at low dialysate flow<br>* Daily hemodialysis at low dialysate flow during 3 months: 6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis. Other parameters of dialysis (dialysate, dialysis machine, generator, blood flow, anticoagulation) are the same as the reference period of conventional hemodialysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success. | Definition of success: if during the period of daily hemodialysis at low dialysate flow, the patient maintains the absolute value of their pre-dialysis serum creatinine (mid-week dialysis) below the upper limit of the confidence interval established during the 3 months prior to inclusion on 7 values: measurements every 2 weeks for 3 months (retrospective data) and inclusion measurement included (Day 0). Daily hemodialysis at low dialysate flow will be considered as a failure if pre-dialysis serum creatinine values exceed twice successively the upper limit of the confidence interval established for the patient. | Every 2 weeks during 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision). |  | 3 months. | 
| Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow. |  | 3 months. | 
| Evaluation of weight. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of blood pressure. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of heart rate. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of body mass index. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of metabolic parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of hematological parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. | During 3 months (retrospectively and prospectively). | 
| Evaluation of inflammation parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): monthly. | During 3 months (retrospectively and prospectively). | 
| Evaluation of nutrition parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): monthly. | During 3 months (retrospectively and prospectively). | 
| Evaluation of iron parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): monthly. | During 3 months (retrospectively and prospectively). | 
| Change in hormones. | Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow. | At inclusion and at 3 months. | 
| Composite measurement of treatments. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): at each hemodialysis. A listing of all the therapeutics changes made between the two dialysis periods will be provided (e.g. dose of erythropoietin, phosphate binders, antihypertensive drugs, other treatments) | During 3 months (retrospectively and prospectively). | 
| Composite measurement of technical dialysis parameters. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. Detail of time frame during 3 months (retrospectively and prospectively): every 2 weeks. A listing of all the technical dialysis changes made between the two dialysis periods will be provided (e.g. urea clearance of the dialysis machine, effective duration of dialysis, ultrafiltration time rate and per dialysis, type of access, blood flow, dialysate flow rate, dialysate composition and anticoagulation method). | During 3 months (retrospectively and prospectively). | 
| List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications. | The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow. | At each hemodialysis during 3 months (retrospectively and prospectively). | 
| Change in quality of life. | Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow. | At inclusion and at 3 months. | 
| Change in pain. | Measurement at inclusion represent the retrospective period of 3 months in conventional hemodialysis. Measurement at 3 months represent the prospective period of 3 months in daily hemodialysis at low dialysate flow. | At inclusion and at 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short daily hemodialysis, Low dialysate flow, End stage renal disease