Peri-dialytic Cardiac RhythmsNCT05814146
Trial of Variable Dialysate Bicarbonate
A study testing Dialysate bicarbonate concentration and Dialysate bicarbonate concentration - telemetry monitoring in people with Peri-dialytic Cardiac Rhythms and Intradialytic Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes
- What is being tested?
- Dialysate bicarbonate concentration and Dialysate bicarbonate concentration - telemetry monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- prevalent end-stage renal disease, on maintenance HD > 90 days
- age ≥ 18 years old
- thrice weekly HD
Who cannot join
- hemoglobin < 8.0 g/dL
- pregnancy
- any physical, mental or medical condition which limited the ability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Katherine S Ravi, MD, MPH, 617-732-6383
About this study
Official title: Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
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
- Being tested
- Dialysate bicarbonate concentration, Dialysate bicarbonate concentration - telemetry monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate bicarbonate concentrationDrug
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 monitoringDevice
Patients will be monitored with telemetry on both arms of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Lower dialysate bicarbonate | Experimental | A lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L). Receives: Drug: Dialysate bicarbonate concentration; Device: Dialysate bicarbonate concentration - telemetry monitoring |
| Higher dialysate bicarbonate | Active comparator | A higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L). Receives: Drug: Dialysate bicarbonate concentration; Device: Dialysate bicarbonate concentration - telemetry monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc prolongation
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.
Measured: During hemodialysis procedure (during dialysate administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start24 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-dialytic Cardiac RhythmsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Scovner Ravi, MD, MPH, Brigham and Women's Hospital
- Investigators
- Katherine S Ravi, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05814146
- Sponsor's protocol ID
- 2022P002944
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05814146
- Acronym / sponsor ID
- 2022P002944
- Conditions
- Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension, Electrolyte Changes, pH Changes, Adverse Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower dialysate bicarbonate | Experimental | Drug: Dialysate bicarbonate concentration, Device: Dialysate bicarbonate concentration - telemetry monitoringA lower dialysate bicarbonate will be used in the experimental arm (30 mEq/L). |
| Higher dialysate bicarbonate | Active comparator | Drug: Dialysate bicarbonate concentration, Device: Dialysate bicarbonate concentration - telemetry monitoringA higher dialysate bicarbonate will be used in the active comparator arm (35 mEq/L). |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prevalent end-stage renal disease, on maintenance HD > 90 days
- age ≥ 18 years old
- thrice weekly HD
Key exclusion criteria (3 listed)
- hemoglobin < 8.0 g/dL
- pregnancy
- any physical, mental or medical condition which limited the ability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysate bicarbonate concentrationAssess 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 | Drug | Higher dialysate bicarbonate, Lower dialysate bicarbonate |
| Dialysate bicarbonate concentration - telemetry monitoringPatients will be monitored with telemetry on both arms of the trial. | Device | Higher dialysate bicarbonate, Lower dialysate bicarbonate |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine S Ravi, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialysate bicarbonate concentration and Dialysate bicarbonate concentration - telemetry monitoring in people with Peri-dialytic Cardiac Rhythms and Intradialytic Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine S Ravi, MD, MPH ((617) 732-6383, ksravi@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc prolongation (time frame: During hemodialysis procedure (during dialysate administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.