Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05814146 · ClinicalTrials.gov registry record · NA
Trial of Variable Dialysate Bicarbonate
A NA study of Intradialytic Hypotension and Peri-dialytic Cardiac Rhythms, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 141
- Enrollment target
- 1
- Study location
NCT05814146: Recruiting NA study of Intradialytic Hypotension and Peri-dialytic Cardiac Rhythms, sponsored by Brigham and Women's Hospital.
NCT05814146 is a NA study of Intradialytic Hypotension and Peri-dialytic Cardiac Rhythms that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 141 participants, above the 60-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target (135% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05814146, a NA study of Intradialytic Hypotension and Peri-dialytic Cardiac Rhythms, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 141 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Dialysate bicarbonate concentration
- DEVICE Dialysate bicarbonate concentration - telemetry monitoring
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2026-10-01 |
| Phase | NA |
What NCT05814146 shows while recruiting
NCT05814146 is an interventional study that assigns participants to a tested intervention. The registered 141 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target (135% higher).
The record links to 5 conditions, with Intradialytic Hypotension appearing as the primary indexed condition, and to 2 interventions - of which Dialysate bicarbonate concentration is the first listed.
NCT05814146 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05814146 about?
NCT05814146 is a clinical study titled "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 ...
What is the current status of trial NCT05814146?
This trial is currently recruiting. It is a NA study. The enrollment target is 141 participants. The study started on 2023-08-24. Estimated completion is 2026-10-01.
What conditions does trial NCT05814146 study?
This clinical trial studies the following conditions: Intradialytic Hypotension, Peri-dialytic Cardiac Rhythms, Electrolyte Changes, pH Changes, Adverse Symptoms.
What interventions are being tested in trial NCT05814146?
The interventions under investigation include: Dialysate bicarbonate concentration (DRUG), Dialysate bicarbonate concentration - telemetry monitoring (DEVICE).
Who is sponsoring clinical trial NCT05814146?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05814146 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Intradialytic Hypotension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03042962 · 141 participants
Brain Networks in Dystonia
- NCT04378439 · 141 participants · NA
Appalachian Partnership to Reduce Disparities (Aim 2)
- NCT04775485 · 141 participants · Phase 2
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
- NCT05040360 · 141 participants · Phase 2
Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI