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Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Primary Purpose

Intra-dialytic Hypotension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-dialytic Hypotension focused on measuring Hemodialysis, Hypotension, Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lower dialysate sodium

Higher dialysate sodium

Arm Description

Dialysate sodium concentration of 138 mmol/L

Dialysate sodium concentration of 142 mmol/L

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Pre-dialysis High-sensitivity Troponin I
Cardiac injury biomarkers

Full Information

First Posted
May 13, 2014
Last Updated
October 2, 2022
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02145260
Brief Title
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Official Title
Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-dialytic Hypotension
Keywords
Hemodialysis, Hypotension, Hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower dialysate sodium
Arm Type
Active Comparator
Arm Description
Dialysate sodium concentration of 138 mmol/L
Arm Title
Higher dialysate sodium
Arm Type
Experimental
Arm Description
Dialysate sodium concentration of 142 mmol/L
Intervention Type
Drug
Intervention Name(s)
Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
Intervention Description
A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
Intervention Type
Drug
Intervention Name(s)
Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
Intervention Description
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
Primary Outcome Measure Information:
Title
Change in Intra-dialytic Decline in Systolic Blood Pressure
Description
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.
Time Frame
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 Measure Information:
Title
Change in Pre-dialysis High-sensitivity Troponin I
Description
Cardiac injury biomarkers
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Finnian Mc Causland, MB, MMSc
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

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