Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2019 |
Start Date: | July 1, 2014 |
End Date: | December 31, 2019 |
Contact: | Finnian Mc Causland, MB, MMSc |
Email: | fmccausland@partners.org |
Randomized 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.
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.
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
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