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

A

Association Pour L'utilisation Rein Artificiel Région Lyonnaise

Status

Terminated

Conditions

End Stage Renal Disease

Treatments

Other: Daily hemodialysis at low dialysate flow

Study type

Interventional

Funder types

Other

Identifiers

NCT01845012
2012-A00307-36

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Daily hemodialysis at low dialysate flow
Experimental group
Treatment:
Other: Daily hemodialysis at low dialysate flow

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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