Incremental Haemodialysis in Incident Patients (IHDIP)

Assessment of the Incremental Haemodialysis Security and Effectiveness in Incident Patients

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.

Study Overview

Detailed Description

Conventional thrice-weekly HD for 3 to 5 hours in a health center in an outpatient basis is the most used renal replacement therapy (RRT) regimen (1). However, it has an unacceptable high mortality rate (10%-20% a year). In order to try to improve those results, new regimens have been proposed. They are based on an increase of the HD dose and/or a higher number of sessions (2). Nevertheless, inconsistent results in terms of clinical benefits with such programs have been shown in recently published randomized and controlled trials (3,4), together with a lower rate of vascular access success (5) and a lower maintenance of the RRF (6) The National Kidney Foundation-Kidney Disease Outcomes Quality Initiate (NKD KDOQI 2015)(1) 2015 guidelines allow the reduction in the weekly HD dose for patients with a residual kidney urea clearance (KrU) higher than 3ml/min/1.73m2. In these cases, the renal clearance (Kr) is added to the dialysis clearance (Kd) obtained in 2 sessions per week, thus obtaining the adequate dialysis dose (7,8) Surprisingly enough, few centers follow this recommendation when over 50% of patients start HD with KrU >3 mL/min (9).

Authors like Kalantar-Zadeh et al (9,10) in the U.S.A. or Teruel et al (11) in Spain have published their experience with 2 HD sessions per week in incident patients. Through this regime they have shown that the RRF is preserved and the survival rate is similar to the one obtained with the conventional HD. This is due to the fact that the Kr has much greater clinical weight than Kd7, since the RRF contributes to the production of vitamin D and erythropoietine (12,13), and eliminates the protein-bound uremic toxins that are poorly dialyzed (13,14). In other words, the RRF plays a fundamental role both in the dialysis adequacy and in survival (15,16).

Currently, some authors are questioning the number of HD sessions with which a patient should start the renal replacement therapy (RRT) (7, 17-19). Progressive HD is an initiation regimen adapted to the patient's RRF. The frequency increases as the daily diuretic level declines (7, 17-19).

The IHDIP trial20 aims at determining whether or not starting with one HD session per week reduces mortality in incident patients and its influence in morbidity (hospital admissions), clinical parameters, quality of life and efficiency with regard to the patients who start RRT with the conventional method.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cáceres, Spain, 10003
        • Hospital San Pedro de Alcántara
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • FundeSalud. Junta de Extremadura
    • Cáceres
      • Plasencia, Cáceres, Spain, 10600
        • Hospital Virgen del Puerto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged >18 years, incident patients with stage 5 CKD who have chosen HD as RRT initiation.
  • RRF measured by KrU ≥ 4 ml/min/1.73m2. In general, it is advised not to start HD with a KrU> 7.
  • Informed consent signed before starting any activity related to the trial.

Exclusion Criteria:

  • Unplanned HD initiation (established in point 7.4 of the protocol)
  • Non incident patients, in other words, patients who were previously on RRT, either on peritoneal dialysis, or on kidney transplant.
  • Active neoplasia at the moment of inclusion
  • Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA), unstable angina or ischemic cardiopathy which has caused any admission in hospital in the last 3 months.
  • Cardiorenal syndrome
  • Active inflammatory disease with immunosuppressive treatment
  • Hepatorenal syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
76 patients who start RRT with the incremental HD regimen.
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
Active Comparator: Control group
76 patients who start RRT with the conventional HD (3 sessions per week)
It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 24 months
Assess and compare survival in subjects with one session a week as an RRT starting regimen, compared to those patients who start RRT with the conventional method
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital admissions
Time Frame: 24 months
Number of hospitalizations, for any cause; and number of days hospitalized for any cause
24 months
Residual Kidney Function (RRF) maintenance .
Time Frame: 24 months
Reduction of glomerular filtration rate (GFR) and tubular function. Average urine volume and percentage of patients with anuria (≤200ml/day in two consecutive measurements).
24 months
Analysis of anemia
Time Frame: 3, 6, 9, 12, 18 and 24 months
Mean hemoglobin levels and Proportion of patients with Hb measurement inside the target range (10.5-12 g/dl) and The erythropoietin resistance index (ERI): ERI = weekly EPO (in UI)/patient's weight (in kg)/Hb (in gr/dl)
3, 6, 9, 12, 18 and 24 months
Bone-mineral metabolism
Time Frame: 3, 6, 9, 12, 18 and 24 months
Mean levels of calcium, phosphorus and intac PTH levels. Estimate the percentage of patients within the therapeutic range; Calcium 8,4-9,5mg/dl, Phosphorus 3,5-5,5mg/dl and iPTH 150-300 pg/dl.
3, 6, 9, 12, 18 and 24 months
Hypertrophic cardiomyopathy levels
Time Frame: Basal, anual and end of the follow-un visit
Basal, anual and end of the follow-un visit
Estimation of the effect of treatment on quality of life
Time Frame: 3, 6, 9, 12, 18 and 24 months
Quality of life survey values from Kidney Disease and Quality of Life (KDQOL'36 Spanish) will be registered.
3, 6, 9, 12, 18 and 24 months
Assessing RRT efficiency (costs)
Time Frame: 12 and 24 months
The number of sessions perform in subjects of incremental HDF group Vs number of sessions in the conventional HD group. The cost of each session is defined by the public contest for private haemodialysis clinics arranged by (that work to) the Health Service of Extremadura.
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Anticipated)

June 6, 2024

Study Completion (Anticipated)

September 6, 2024

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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