Dialysate Sodium Lowering Trial

Completed · Phase 2

Conditions studied: Hemodialysis Complication, Fluid Overload, Dialysis Disequilibrium, Intra-dialytic Hypotension, Hypertension

In brief

This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.

Key facts

Study ID

NCT03144817

Run by

Tufts Medical Center

People needed

44

Starts

2017-04-26

Expected to finish

2019-04-02

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Patients undergoing thrice weekly in-center conventional HD
• At least 90 days since start of hemodialysis
• Absence of pulmonary edema / signs of fluid overload on physical exam
• Currently dialyzing at a DNa >=137 mEq/L
• Single session Kt/V >=1.3 each month for the past 2 months
• Hypertensive, defined by a pre-dialysis BP of >140/90 or treatment with 1 or more antihypertensive agents
• No more than 1 skipped treatment and no more than 1 session per month shortened by >10 min
• Life expectancy >12 months
• Able to provide Informed Consent
• Speaks and understands English

You may not qualify if…

• Prone to IDH, defined as IDH occurring in >10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP <90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
• Pregnancy

Where it is running

• DCI Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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