Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

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.

Study Overview

• Status: Completed
• Conditions: Intra-dialytic Hypotension
• Intervention / Treatment: Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate); Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Lower dialysate sodium; Dialysate sodium concentration of 138 mmol/L	Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate); A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
EXPERIMENTAL: Higher dialysate sodium; Dialysate sodium concentration of 142 mmol/L	Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate); A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intra-dialytic Decline in Systolic Blood Pressure	Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.	Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pre-dialysis High-sensitivity Troponin I	Cardiac injury biomarkers	The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Finnian Mc Causland, MB, MMSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: May 13, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (ESTIMATE): May 22, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Hypotension; Hemodialysis; Hospitalization
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 2014P000629