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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 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 144 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145260
The ClinicalTrials.gov registry entry for NCT02145260 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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