Clinical trial NCT01845012: Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
Official title: Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Short daily hemodialysis
Low dialysate flow
End stage renal disease
Lead sponsor: Association Pour L'utilisation Rein Artificiel Région Lyonnaise
Sponsor class: OTHER
Collaborators: name: Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)
First posted: 2013-05-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
timeFrame: Every 2 weeks during 3 months.
Secondary outcomes:
measure: Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).
timeFrame: 3 months.
measure: Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.
timeFrame: 3 months.
measure: Evaluation of weight.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of blood pressure.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of heart rate.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of body mass index.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of metabolic parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of hematological parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of inflammation parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of nutrition parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Evaluation of iron parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Change in hormones.
timeFrame: At inclusion and at 3 months.
measure: Composite measurement of treatments.
timeFrame: During 3 months (retrospectively and prospectively).
measure: Composite measurement of technical dialysis parameters.
timeFrame: During 3 months (retrospectively and prospectively).
measure: List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications.
timeFrame: At each hemodialysis during 3 months (retrospectively and prospectively).
measure: Change in quality of life.
timeFrame: At inclusion and at 3 months.
measure: Change in pain.
timeFrame: At inclusion and at 3 months.
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires St Luc
city: Angers
country: France
facility: ECHO Angers
city: Bordeaux
country: France
facility: CTMR Saint Augustin
city: Cherbourg
country: France
facility: CHPC
city: Grenoble
country: France
facility: CHU Grenoble
city: Le Petit Quevilly
country: France
facility: ANIDER
city: Lyon
country: France
facility: AURAL
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital Edouard Herriot
city: Meylan
country: France
facility: AGDUC Meylan
city: Paris
country: France
facility: AURA - Paris
city: Pierre-benite
country: France
facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
city: Reze
country: France
facility: ECHO Nantes
city: Vichy
country: France
facility: Centre Hospitalier de Vichy
Study officials:
affiliation: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service de Néphrologie Bâtiment 3C, 3ème étage, Chemin du grand Revoyet 69495 PIERRE-BENITE
name: Maurice Laville, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: