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The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Mar 2025 to Apr 2, 2024 Completion date: Sep 2025 to Jul 2026v5 Show 1 more changeShow less
    • Completion date: Sep 2025 to Jul 2026
  2. Primary completion date: Sep 2023 to Mar 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Sep 2023 to Sep 2025 · Site details revised at 2 of 2 sitesv4 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Sep 2023 to Sep 2025
    • Site details revised at 2 of 2 sites
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2019 to Sep 16, 2019v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2019 to Sep 16, 2019
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Protein-energy wasting (PEW), a hypercatabolic state characterized by loss of muscle mass and fuel reserves, is highly prevalent in hemodialysis patients. Nutritional status and body composition are closely linked to morbidity, mortality and quality of life. Lean tissue mass (LTM) appears to be the best read-out for the association between nutritional status and outcomes. Intradialytic parenteral nutrition (IDPN) is occasionally used with the aim to reduce loss of LTM, but its efficacy has not been established. The goal of this study is to study the effect of IDPN on changes in LTM in hemodialysis patients.
Trial Details
NCT Number NCT04094038
Lead Sponsor Erasmus Medical Center
Collaborators: Baxter Healthcare Corporation
Conditions End Stage Renal Disease, Malnutrition, Sarcopenia, Hemodialysis Complication
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov