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-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.
|Intra-dialytic Hypotension||Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients|
- Magnitude of intra-dialytic decline in systolic blood pressure [ Time Frame: Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period ]
- Change in pre-dialysis high-sensitivity troponin I [ Time Frame: The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days ]
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Lower dialysate sodium
Dialysate sodium concentration of 138 mmol/L
Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
Experimental: Higher dialysate sodium
Dialysate sodium concentration of 142 mmol/L
Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02145260
|Contact: Finnian Mc Causland, MB, MMScfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Finnian Mc Causland, MB, MMSc email@example.com|
|Sub-Investigator: Sushrut Waikar, MD, MPH|
|Principal Investigator:||Finnian Mc Causland, MB, MMSc||Brigham and Women's Hospital|