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NCT02145260 · ClinicalTrials.gov registry record · NA
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
NCT02145260: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT02145260 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 144 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02145260, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
Study Summary
Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality. Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD. This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia. The investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.
Primary Outcome
Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.
Interventions
- DRUG Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
- DRUG Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2014-07-01 |
| Est. Completion | 2021-05-03 |
| Phase | NA |
What the finished NCT02145260 record still lists
NCT02145260 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) is the first listed.
NCT02145260 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02145260 about?
NCT02145260 is a clinical study titled "Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients". Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo...
What is the current status of trial NCT02145260?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2014-07-01. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT02145260?
The interventions under investigation include: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) (DRUG), Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) (DRUG).
Who is sponsoring clinical trial NCT02145260?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02145260's enrollment target sits among peer trials
144 706th of 2000 higher than 1,290 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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