Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Mass General Brigham

Status: Completed

Conditions: Intra-dialytic Hypotension

Treatments: Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate); Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Study type: Interventional

Funder types: Other

Identifiers

NCT02145260

2014P000629

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HD (>90 days)
• Age ≥18y
• Informed consent
• First admission during study period.

Exclusion criteria

• Use of pressors
• Pre-dialysis serum sodium <=128mmol/L or > 145 mmol/L
• Pre-dialysis SBP >180 mmHg
• Intensive care stay earlier in admission
• Expected length of stay <24 hours (e.g. admission for HD access procedure)
• Acute coronary syndrome within seven days
• Acute stroke
• Institutionalized individuals
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

Lower dialysate sodium

Active Comparator group

Description:

Dialysate sodium concentration of 138 mmol/L

Treatment:

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

Higher dialysate sodium

Experimental group

Description:

Dialysate sodium concentration of 142 mmol/L

Treatment:

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