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Trial of Variable Dialysate Bicarbonate
QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death. It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions. This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital. The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.
Conditions:
🦠 Peri-dialytic Cardiac Rhythms 🦠 Intradialytic Hypotension 🦠 Electrolyte Changes 🦠 pH Changes 🦠 Adverse Symptoms
🗓️ Study Start (Actual) 24 August 2023
🗓️ Primary Completion (Estimated) 1 September 2026
✅ Study Completion (Estimated) 1 October 2026
👥 Enrollment (Estimated) 141
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * prevalent end-stage renal disease, on maintenance HD \> 90 days
    • * age ≥ 18 years old
    • * thrice weekly HD

    Exclusion Criteria:

    • * hemoglobin \< 8.0 g/dL
    • * pregnancy
    • * any physical, mental or medical condition which limited the ability to provide written informed consent
Ages Eligible for Study: 18 Years to 120 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 20 March 2023
  • First Submitted that Met QC Criteria 3 April 2023
  • First Posted 14 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 February 2024
  • Last Update Posted 26 February 2024
  • Last Verified February 2024
I'm interested ...!!