NCT02145260

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-dialytic Hypotension

Interventions

Type	Name	Description
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)
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)

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-12-31
• Completion: 2021-05-03
• First posted: 2014-05-22
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

1 site across 1 country: United States