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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05814146
The ClinicalTrials.gov registry entry for NCT05814146 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 141 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 60-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target (135% higher). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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