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NCT Number: NCT05814146

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.

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Key information

Conditions

Peri-dialytic Cardiac Rhythms Adverse Symptoms Electrolyte Changes Intradialytic Hypotension pH Changes

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Katherine S Ravi, MD, MPH

CONTACT

617-732-6383

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysate bicarbonate concentration

Drug

Assess how a lower dialysate bicarbonate affects:

  • QTc duration during and between hemodialysis sessions
  • PVC burden during and between hemodialysis sessions
  • Clinically significant arrhythmia during and between hemodialysis sessions
  • Intradialytic hypotension
  • Adverse symptoms during hemodialysis sessions

Dialysate bicarbonate concentration - telemetry monitoring

Device

Patients will be monitored with telemetry on both arms of the trial.

Primary outcomes

  1. QTc prolongation

    Time frame: During hemodialysis procedure (during dialysate administration)

    QTc prolongation, calculated as post-HD (just as HD finishing, generally 4 hours from start of HD session) minus pre-HD QTc duration, will be obtained via Holter monitoring.

Other outcomes

  1. PVC frequency

    Time frame: PVCs/hour will be recorded during HD sessions and for ~44-68 hours from the end of the hemodialysis session until the subsequent hemodialysis session.

    Holter monitors will be used to assess PVC frequency during HD sessions and in the subsequent inter-HD period. The investigators will also assess PVC coupling interval variability in these time intervals.

  2. Clinically significant arrhythmia

    Time frame: Clinically significant arrhythmia will be assessed during hemodialysis sessions and in the subsequent inter-hemodialysis period (until the subsequent hemodialysis session, up to 68 hours).

    As described in the Monitoring in Dialysis (MiD) study, clinically significant arrhythmia is defined as: sustained ventricular tachycardia, bradycardia, asystole and symptomatic arrhythmias.

  3. Intradialytic hypotension

    Time frame: Blood pressures will be measured every 15 minutes during HD sessions.

    Intradialytic hypotension will be defined as systolic blood pressure <90 during hemodialysis. The investigators will also conduct sensitivity analyses using alternative definitions of intradialytic hypotension (e.g. nadir intra-hemodialysis systolic blood pressure <90mmHg if pre-hemodialysis systolic blood pressure is <160mmHg or nadir intra-hemodialysis systolic blood pressure <100mmHg if pre-hemodialysis systolic blood pressure is ≥160mmHg). Additionally, the investigators will examine the overall mean decline in systolic blood pressure during hemodialysis as a continuous outcome (intra-hemodialysis systolic blood pressure decline=pre-hemodialysis systolic blood pressure minus nadir systolic blood pressure during hemodialysis).

  4. Electrolytes

    Time frame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).

    Samples are collected from the hemodialysis circuit (no extra blood sticks) for freezing for comprehensive metabolic panels.

  5. pH

    Time frame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).

    Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate blood gas analysis.

  6. Ionized calcium level

    Time frame: Obtained pre- and post-hemodialysis study sessions (just as hemodialysis finishing, generally 4 hours from start of hemodialysis session).

    Samples are collected from the hemodialysis circuit (no extra blood sticks) for immediate evaluation of ionized calcium level.

  7. Adverse symptoms

    Time frame: Questionnaires will be administered during the last 10 minutes of hemodialysis sessions.

    The investigators will administer the modified Edmonton Symptom Assessment System (mESAS). The mESAS measures patient-reported severity of pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath and pruritus using a 0-10 score (anchored by "No" at 0 and "Severe" at 10). A validated Spanish version is available and a translator will help to administer the questionnaire as well as with all communication with patients in any language other than English.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine S Ravi, MD, MPH

CONTACT

[email protected]

(617) 732-6383

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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