CompletedNCT02145260Updated Oct 31, 2022Results posted

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

An interventional study of Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) and Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) in Intra-dialytic Hypotension, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-31.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 144
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Intra-dialytic Hypotension

Browse trials for

Hypotension 1,003

Keywords

Hemodialysis
Hypotension
Hospitalization

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 144 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Chronic HD (>90 days)
Age ≥18y
Informed consent
First admission during study period.

Exclusion criteria

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 144 participants (actual)

Study arms

Active comparator
Lower dialysate sodium
Dialysate sodium concentration of 138 mmol/L
Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
Experimental
Higher dialysate sodium
Dialysate sodium concentration of 142 mmol/L
Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Interventions

DrugLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
DrugHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

What researchers measure

Primary outcomes

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.
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 outcomes

Change in Pre-dialysis High-sensitivity Troponin I
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

Results

Posted Oct 31, 2022

Participant flow

Participant flow — Overall Study
Milestone	Lower Dialysate Sodium	Higher Dialysate Sodium
Started	69	70
Completed	69	70
Not completed	0	0

Outcome measures

PrimaryChange 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.

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
Reported as:: Mean · mm Hg

Change in Intra-dialytic Decline in Systolic Blood Pressure
mm Hg	Lower Dialysate Sodium	Higher Dialysate Sodium
Change in Intra-dialytic Decline in Systolic Blood Pressure	26 ± 16	23 ± 16

SecondaryChange in Pre-dialysis High-sensitivity Troponin I

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

No measurements were reported for this outcome.

Adverse events

Collected over From randomization to maximum of 6 inpatient study sessions (two-week period). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lower Dialysate Sodium	0/69 (0%)	1/69 (1.4%)	28/69 (40.6%)
Higher Dialysate Sodium	0/70 (0%)	1/70 (1.4%)	24/70 (34.3%)

Most frequent serious events

Most frequent serious events
Event	Lower Dialysate Sodium	Higher Dialysate Sodium
NSTEMI non-ST segment elevation myocardial infarctionCardiac disorders	1/69	0/70
post-operative bleedBlood and lymphatic system disorders	0/69	1/70

Most frequent other events

Most frequent other events
Event	Lower Dialysate Sodium	Higher Dialysate Sodium
HypotensionCardiac disorders	9/69	6/70
CrampingMusculoskeletal and connective tissue disorders	7/69	6/70
Hypertension (>180 mmHg)Cardiac disorders	3/69	7/70
Other painNervous system disorders	5/69	4/70
Chest pain/myocardial infarctionCardiac disorders	4/69	1/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Lower Dialysate Sodium	Higher Dialysate Sodium	Total
Mean	61 ± 14	58 ± 15	59.5 ± 14.5

Sex: Female, Male
Sex: Female, Male(Participants)	Lower Dialysate Sodium	Higher Dialysate Sodium	Total
Female	26	34	60
Male	43	36	79

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Lower Dialysate Sodium	Higher Dialysate Sodium	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	21	25	46
White	38	34	72
More than one race	0	0	0
Unknown or Not Reported	10	10	20

Region of Enrollment
Region of Enrollment(participants)	Lower Dialysate Sodium	Higher Dialysate Sodium	Total
United States	69	70	139

Diabetes
Diabetes(Participants)	Lower Dialysate Sodium	Higher Dialysate Sodium	Total
Count of participants	36	39	75

Study locations

1 site

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

References and documents

Study documents

Protocol and statistical analysis plan · Aug 1, 2017

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02145260
Lead sponsor: Brigham and Women's Hospital
Responsible party: Finnian McCausland (Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital) — Principal investigator
First posted: May 22, 2014
Start date: Jul 1, 2014
Primary completion: Dec 31, 2020
Completion: May 3, 2021
Results posted: Oct 31, 2022
Last update: Oct 31, 2022

Study contacts

Finnian Mc Causland, MB, MMSc

principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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