Clinical Trial: Dialysate Sodium Lowering Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dialysate Sodium Lowering Trial

Brief Summary: 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.

Detailed Summary: This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).
Sponsor: Tufts Medical Center

Current Primary Outcome:

• Frequency of Intradialytic Hypotension [ Time Frame: Baseline period through study completion, an average of 6 months ]

  IDH is determined by review of blood pressures (measured every 30 minutes during dialysis), symptoms (recorded by the nurse during the dialysis treatment and reviewed at Q2 weekly face to face visits by the study team) and the need for intervention (targeted ultrafiltration goal was reduced; treatment was terminated early or saline given for intradialytic hypotension. IDH is defined by any 1 (or more of the following) 1) lowest intradialytic Systolic BP <90 mm Hg or 2) intradialytic symptoms (cramps, lightheadedness, nausea +/-vomiting, diaphoresis, loss of consciousness or seizure) OR 3) intervention performed for symptoms of IDH or lowest intradialytic BP <90 mm Hg.

  The # IDH events (meeting 1 or more of the 3 criteria above) per 100 treatments will be compared across treatment arms.

• Dialysis Dysequilibrium (Safety) [ Time Frame: Baseline period through study completion, an average of 6 months ]
  Ascertained via self-report on a questionnaire that asks about the frequency of symptoms suggestive of DD occurring during or immediately after dialysis. The symptoms are: headache, nausea +/- vomiting, confusion, drowsiness, muscle twitching, blurred vision. There are 5 response options ranging from never through to very often for each question. The questionnaire is administered at baseline, at 6 weeks, and Q3 months thereafter. The change in frequency of each symptom will be compared across arms.
• Frequency of ER visits and hospitalizations (safety) [ Time Frame:&
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Pre- and post-dialysis Plasma Sodium [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Taken from lab draws immediately before and after start of dialysis treatment.
  • Dialysate Sodium [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Sample of dialysate sodium taken 30 minutes after start of dialysis treatment.
  • Relative Blood Volume [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined using CRIT LINE III monitors.
  • Bioimpedance Analysis [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Water volume and bioimpedance results will be determined using InBodyS10 device.
  • Interdialytic Weight Gain [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.
  • Post Dialysis Weight [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.
  • Estimated Dry Weight [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.
  • Pre- and Post-dialysis Sitting Blood Pressure [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.
  • Home Blood Pressure Monitoring [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Participants will use a LifeSource blood pressure monitor to measure their blood pressure weekly at home.
  • Sodium Loss during Dialysis [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Calculated according to the formula: pre-dialysis total body Na - post-dialysis total body Na, where the volume of distribution in the extracellular space is estimated as 0.58*target weight.
  • Thirst and Xerostomia [ Time Frame: Baseline through study completion, an average of 6 months ]

    Thirst and Xerostomia will be measured via validated, self-administered questionnaires, the 'Dialysis Thirst Inventory' and the 'Xerostomia Inventory' , respectively (BotsCP et al, Kidney International:66; 2004).

    Change in each inventory score from baseline to the end of the study will be compared by treatment arm.

  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: Tufts Medical Center
  

  Dates:
  Date Received: April 27, 2017
  Date Started: April 26, 2017
  Date Completion: February 2019
  Last Updated: May 4, 2017
  Last Verified: May 2017