Incremental Hemodialysis as a Starting Way of Renal Replacement Therapy
1 other identifier
interventional
150
1 country
1
Brief Summary
The Hemodialysis Unit of the Hospital Ramon y Cajal is a pioneer in the implementation of a program of incremental hemodialysis, starting with two sessions a week in patients with residual renal function. The main objective is to compare whether the initiation of hemodialysis with two sessions a week over conventional pattern of initiation of three sessions a week better preserves residual renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 13, 2024
May 1, 2024
5.7 years
July 3, 2017
May 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Asses the loss of residual renal function in patients who started chronic hemodialysis
Assess the loss of renal function evolution in patients starting hemodialysis therapy 2 days per week, versus patients with hemodialysis 3 days per week.
Measurements of multiple variables to measure renal function each two months during one year period
Study Arms (2)
Incremental Hemodialysis
ACTIVE COMPARATORSubjects on this arm will be treated with 2 hemodialysis sessions of at least 4 hour per week.
Conventional hemodialysis
ACTIVE COMPARATORSubjects on this arms will be treated with 3 hemodialysis sessions of at least 3.5 hour per week.
Interventions
Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week
Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week
Eligibility Criteria
You may qualify if:
- Subjects starting renal replacement therapy from January 2017 to June 2018.
- Subjects who consent to sign the Informed Consent Form.
- Subject who maintain residual diuresis and urea clearance equal or superior to 2,5 ml/min.
You may not qualify if:
- Anuric patients.
- Patients with acute renal failure.
- Patients who revoke the Informed Consent Form.
- Patients who start hemodialysis after having going through a renal transplant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Ramón y Cajal
Madrid, 28034, Spain
Related Publications (1)
Fernandez Lucas M, Ruiz-Roso G, Merino JL, Sanchez R, Bouarich H, Herrero JA, Muriel A, Zamora J, Collado A. Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial. Trials. 2020 Feb 19;21(1):206. doi: 10.1186/s13063-020-4058-0.
PMID: 32075665DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2017
First Posted
October 5, 2017
Study Start
April 4, 2017
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
May 13, 2024
Record last verified: 2024-05