Incremental Haemodialysis in Incident Patients

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.

Conditions

• Renal Disease, End-Stage

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).

Sponsors & Collaborators

• Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)

  collaborator UNKNOWN

• Hospital San Pedro de Alcantara

  collaborator OTHER

• Virgen del Puerto Hospital

  collaborator OTHER

• Hospital Central de la Defensa Gómez Ulla. Madrid (Spain)

  collaborator UNKNOWN

• Hospital Costa del Sol

  collaborator OTHER

• Hospital Obispo Polanco. Teruel (Spain)

  collaborator UNKNOWN

• Hospital de Manises. Valencia (Spain)

  collaborator UNKNOWN

• Hospital Virgen de la Concha. Zamora (Spain)

  collaborator UNKNOWN

• Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)

  collaborator UNKNOWN

• Servicio Extremeño de Salud (Spain)

  collaborator UNKNOWN

• Hospital del SAS de Jerez

  collaborator OTHER

• Hospital Nuestra Sra de Sonsoles. Ávila (Spain)

  collaborator UNKNOWN

• Dialysis Center SM2. Potenza (Italy)

  collaborator UNKNOWN

• Miulli General Hospital

  collaborator OTHER

• Hospital del Rio Hortega

  collaborator OTHER

• Hospital Duran de Buenos Aires

  collaborator UNKNOWN

• Hospital El Bierzo

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Hospital Universitario Virgen Macarena

  collaborator OTHER

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

  lead OTHER

Principal Investigators

• Javier L Deira Lorenzo, PhD MD · Servicio Extremeño de Salud

• Miguel A Suarez Santisteban, MD · Servicio Extremeño de Salud

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-14

Primary Completion

2024-06-06

Completion

2025-06-30

Countries

• Spain

Study Locations