CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 144 enrolled
Drug / intervention
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02145260
NCT02145260N/ACompleted

Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Brigham and Women's Hospital·interventional·Posted May 22, 2014·Updated Oct 31, 2022

In Brief

A clinical study evaluating Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) and Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) for Intra-dialytic Hypotension. Completed, enrolled 144 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 22, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 31, 2020
Study CompletionMay 3, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 12.1 years ago

Interventions

Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)drug

A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)

Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)drug

A higher dialysate sodium will be used in the experimental arm (142 mmol/L)