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ACTIVE NOT RECRUITING
NCT03239808
NA

Incremental Haemodialysis in Incident Patients

Sponsor: Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

View on ClinicalTrials.gov

Summary

Background: Incremental hemodialysis (HD) is a starting regime for renal replacement therapy (RRT) adapted to each patient's necessities. It is mainly conditioned by the residual renal function (RRF). The frequency of sessions with which patients start HD -one or two sessions per week-, is lower than that for conventional HD three times per week. Such frequency is increased (from one to two sessions, and from two to three sessions) as the RRF declines. Methods/Design: IHDIP is a multicenter randomized experimental open trial. It is randomized in a 1:1 ratio and controlled through usual clinical practice, with a low intervention level and non-commercial. It includes 152 patients older than 18 years with chronic renal disease stage 5 and start HD as RRT, with a RRF of ≥ 4ml/min/1.73m2, measured by renal clearance of urea (KrU). The intervention group includes 76 patients who will start with one session of HD per week (incremental HD). The control group includes 76 patients who will start with three sessions per week (conventional HD). The primary purpose is assessing the survival rate, while the secondary purposes are the morbidity rate (hospital admissions), the clinical parameters, the quality of life and the efficiency. Discussion: This study will enable us to know with the highest level of scientific evidence, the number of sessions a patient should receive when starting the HD treatment, depending on his/her RRF.

Official title: Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2018-03-14

Completion Date

2025-06-30

Last Updated

2025-03-05

Healthy Volunteers

No

Interventions

PROCEDURE

Incremental haemodialysis

It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression

PROCEDURE

Conventional haemodialysis

It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).

Locations (3)

FundeSalud. Junta de Extremadura

Mérida, Badajoz, Spain

Hospital Virgen del Puerto

Plasencia, Cáceres, Spain

Hospital San Pedro de Alcántara

Cáceres, Spain