Dialysate Sodium Lowering Trial

NCT03144817 | Completed Phase 2 DMC

• 1 other identifier: 12393
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Fluid Overload; Dialysis Disequilibrium; Intra-dialytic Hypotension; Hypertension

Keywords

hemodialysis; fluid overload; dialysis disequilibrium; intra-dialytic hypotension; dialysate sodium lowering

Outcome Measures

Primary Outcomes (4)

• Frequency of Intradialytic Hypotension

  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.

  Baseline period through study completion, an average of 6 months

• Dialysis Dysequilibrium (Safety)

  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.

  Baseline period through study completion, an average of 6 months

• Frequency of ER visits and hospitalizations (safety)

  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.

  Baseline through study completion

• Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)

  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.

  Last 2 weeks of Follow-up

Secondary Outcomes (11)

• Pre- and post-dialysis Plasma Sodium

  Baseline period through study completion, an average of 6 months

• Dialysate Sodium

  Baseline period through study completion, an average of 6 months

• Relative Blood Volume

  Baseline period through study completion, an average of 6 months

• Bioimpedance Analysis

  Baseline period through study completion, an average of 6 months

• Interdialytic Weight Gain

  Baseline period through study completion, an average of 6 months

Study Arms (2)

Control Group

NO INTERVENTION

Intervention Group

EXPERIMENTAL

Intervention group will dialyze with dialysate Na 135 mEq/L.

Other: Dialysate Sodium Lowering

Interventions

Dialysate Sodium Lowering OTHER

Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Dialysis Clinic, Inc.: collaborator
• InBody: collaborator

Study Sites (1)

DCI Boston

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

  PMID: 39498822 DERIVED

MeSH Terms

Conditions

Edema; Dysequilibrium syndrome; Hypertension

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dana Miskulin, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 9, 2017
• Study Start: April 26, 2017
• Primary Completion: December 19, 2018
• Study Completion: April 2, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Locations

US (1)