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

NCT01845012 | Terminated

• 1 other identifier: 2012-A00307-36
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 13

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.

Conditions

End Stage Renal Disease

Keywords

Short daily hemodialysis; Low dialysate flow; End stage renal disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• 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.

  During 3 months (retrospectively and prospectively).

• Evaluation of blood pressure.

  During 3 months (retrospectively and prospectively).

• Evaluation of heart rate.

  During 3 months (retrospectively and prospectively).

Study Arms (1)

Daily hemodialysis at low dialysate flow

EXPERIMENTAL

Other: Daily hemodialysis at low dialysate flow

Interventions

Daily hemodialysis at low dialysate flow 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.

Daily hemodialysis at low dialysate flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Pour L'utilisation Rein Artificiel Région Lyonnaise: lead
• Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France): collaborator

Study Sites (13)

Cliniques universitaires St Luc

Brussels, 1200, Belgium

Location

ECHO Angers

Angers, 49055, France

Location

CTMR Saint Augustin

Bordeaux, 33000, France

Location

CHPC

Cherbourg, 50102, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

ANIDER

Le Petit-Quevilly, 76143, France

Location

AURAL

Lyon, 69008, France

Location

Hospices Civils de Lyon - Hôpital Edouard Herriot

Lyon, 69437, France

Location

AGDUC Meylan

Meylan, 38240, France

Location

AURA - Paris

Paris, 75015, France

Location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

ECHO Nantes

Rezé, 44402, France

Location

Centre Hospitalier de Vichy

Vichy, 03201, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maurice Laville, MD, PHD

  Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service de Néphrologie Bâtiment 3C, 3ème étage, Chemin du grand Revoyet 69495 PIERRE-BENITE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: May 3, 2013
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

BE (1); FR (12)