ClinicalTrials.gov
ClinicalTrials.gov Menu

Dialysate Sodium Lowering Trial (DeSaLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03144817
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Dialysis Clinic, Inc.
InBody
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Complication Fluid Overload Dialysis Disequilibrium Intra-dialytic Hypotension Hypertension Other: Dialysate Sodium Lowering Phase 2

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dialysate Sodium Lowering Trial
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Experimental: Intervention Group
Intervention group will dialyze with dialysate Na 135 mEq/L.
Other: Dialysate Sodium Lowering
Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. Frequency of ER visits and hospitalizations (safety) [ Time Frame: Baseline through study completion ]
    The frequency of ER visits and hospitalizations will be ascertained at Q2 weekly study visits. The # of events per time at risk will be compared across treatment arms.

  4. Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility) [ Time Frame: Last 2 weeks of Follow-up ]
    Among those assigned to Dialysate Na 135 mEq/l as the denominator, the # actually continuing to dialyze at this level during the last two weeks of study follow-up.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Relative Blood Volume [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined using CRIT LINE III monitors.

  4. 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.

  5. Interdialytic Weight Gain [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.

  6. Post Dialysis Weight [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.

  7. Estimated Dry Weight [ Time Frame: Baseline period through study completion, an average of 6 months ]
    Determined by analysis of treatment sheets.

  8. 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.

  9. 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.

  10. 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.

  11. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144817


Contacts
Contact: Teresa Wu, BA (617) 636-2571 twu@tuftsmedicalcenter.org

Locations
United States, Massachusetts
DCI Boston Recruiting
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Dialysis Clinic, Inc.
InBody
Investigators
Principal Investigator: Dana Miskulin, MD Tufts Medical Center

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03144817     History of Changes
Other Study ID Numbers: 12393
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Tufts Medical Center:
hemodialysis
fluid overload
dialysis disequilibrium
intra-dialytic hypotension
dialysate sodium lowering

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Dialysis Solutions
Pharmaceutical Solutions