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Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis (HDQ200)

Primary Purpose

End Stage Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Daily hemodialysis at low dialysate flow
Sponsored by
Association Pour L'utilisation Rein Artificiel Région Lyonnaise
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Short daily hemodialysis, Low dialysate flow, End stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques universitaires St Luc
  • ECHO Angers
  • CTMR Saint Augustin
  • CHPC
  • CHU Grenoble
  • ANIDER
  • AURAL
  • Hospices Civils de Lyon - Hôpital Edouard Herriot
  • AGDUC Meylan
  • AURA - Paris
  • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
  • ECHO Nantes
  • Centre Hospitalier de Vichy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daily hemodialysis at low dialysate flow

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).
Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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).
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.
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.
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.

Full Information

First Posted
April 11, 2013
Last Updated
March 16, 2017
Sponsor
Association Pour L'utilisation Rein Artificiel Région Lyonnaise
Collaborators
Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)
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1. Study Identification

Unique Protocol Identification Number
NCT01845012
Brief Title
Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
Acronym
HDQ200
Official Title
Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Study has been prematurely halted because of failure of patient recruitment.
Study Start Date
July 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Pour L'utilisation Rein Artificiel Région Lyonnaise
Collaborators
Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Short daily hemodialysis, Low dialysate flow, End stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily hemodialysis at low dialysate flow
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Daily hemodialysis at low dialysate flow
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients for whom the period of daily hemodialysis at low dialysate flow will be a success.
Description
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.
Time Frame
Every 2 weeks during 3 months.
Secondary Outcome Measure Information:
Title
Number of patients who stopped the daily hemodialysis at low dialysate flow (patient or investigator's decision).
Time Frame
3 months.
Title
Number of patients who maintained a satisfactory clinical condition (investigator assessment) during the period of daily hemodialysis at low dialysate flow.
Time Frame
3 months.
Title
Evaluation of weight.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of blood pressure.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of heart rate.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of body mass index.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of metabolic parameters.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of hematological parameters.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of inflammation parameters.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of nutrition parameters.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Evaluation of iron parameters.
Description
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.
Time Frame
During 3 months (retrospectively and prospectively).
Title
Change in hormones.
Description
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.
Time Frame
At inclusion and at 3 months.
Title
Composite measurement of treatments.
Description
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)
Time Frame
During 3 months (retrospectively and prospectively).
Title
Composite measurement of technical dialysis parameters.
Description
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).
Time Frame
During 3 months (retrospectively and prospectively).
Title
List of symptoms and incidents between two hemodialysis, evaluation of hemodialysis tolerance, clinical assessment of the vascular access and possible local complications.
Description
The retrospective study period is 3 months of conventional hemodialysis. The prospective study period is 3 months of daily hemodialysis at low dialysate flow.
Time Frame
At each hemodialysis during 3 months (retrospectively and prospectively).
Title
Change in quality of life.
Description
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.
Time Frame
At inclusion and at 3 months.
Title
Change in pain.
Description
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.
Time Frame
At inclusion and at 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Laville, MD, PHD
Organizational Affiliation
Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service de Néphrologie Bâtiment 3C, 3ème étage, Chemin du grand Revoyet 69495 PIERRE-BENITE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques universitaires St Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
ECHO Angers
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
CTMR Saint Augustin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHPC
City
Cherbourg
ZIP/Postal Code
50102
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
ANIDER
City
Le Petit Quevilly
ZIP/Postal Code
76143
Country
France
Facility Name
AURAL
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hospices Civils de Lyon - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
AGDUC Meylan
City
Meylan
ZIP/Postal Code
38240
Country
France
Facility Name
AURA - Paris
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
City
Pierre-benite
ZIP/Postal Code
69495
Country
France
Facility Name
ECHO Nantes
City
Reze
ZIP/Postal Code
44402
Country
France
Facility Name
Centre Hospitalier de Vichy
City
Vichy
ZIP/Postal Code
03201
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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