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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-01-31

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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daily hemodialysis at low dialysate flow

Group Type EXPERIMENTAL

Daily hemodialysis at low dialysate flow

Intervention Type OTHER

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.

Interventions

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Daily hemodialysis at low dialysate flow

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.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No