NCT02145260

Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Completed NA Results posted Last updated 31 October 2022

What this trial tests

NA trial testing Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) in Intra-dialytic Hypotension in 144 participants. Completed in 3 May 2021.

Timeline

1 July 2014

Primary endpoint
31 December 2020

3 May 2021

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	144
Start date	1 July 2014
Primary completion	31 December 2020
Estimated completion	3 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) — full drug profile →
• Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) — full drug profile →

Conditions studied

• Intra-dialytic Hypotension — all drugs for Intra-dialytic Hypotension →

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Intra-dialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Intra-dialytic Decline in Systolic Blood Pressure Primary · 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

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.

Group	Value	95% CI
Lower Dialysate Sodium	26	± 16
Higher Dialysate Sodium	23	± 16

Adverse events — posted to ClinicalTrials.gov

Time frame: From randomization to maximum of 6 inpatient study sessions (two-week period). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lower Dialysate Sodium

Serious: 1/69 (1%)

Deaths: 0/69

Higher Dialysate Sodium

Serious: 1/70 (1%)

Deaths: 0/70

Serious adverse events (2 terms)

Reaction	System	Lower Dialysate Sodium	Higher Dialysate Sodium
NSTEMI non-ST segment elevation myocardial infarction	Cardiac disorders	—	—
post-operative bleed	Blood and lymphatic system disorders	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Lower Dialysate Sodium	Higher Dialysate Sodium
Hypotension	Cardiac disorders	—	—
Hypertension (>180 mmHg)	Cardiac disorders	—	—
Cramping	Musculoskeletal and connective tissue disorders	—	—
Other pain	Nervous system disorders	—	—
Chest pain/myocardial infarction	Cardiac disorders	—	—

Most-reported serious reactions: NSTEMI non-ST segment elevation myocardial infarction, post-operative bleed.

Data from ClinicalTrials.gov NCT02145260 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dialysate Sodium: Rationale for Evolution over Time.
   Flythe JE, Mc Causland FR. · · 2017 · cited 31× · PMID 28066913 · DOI 10.1111/sdi.12570
2. Low dialysate sodium levels for chronic haemodialysis.
   Dunlop JL, Vandal AC, Marshall MR. · · 2019 · cited 30× · PMID 30646428 · DOI 10.1002/14651858.cd011204.pub2
3. A randomized controlled trial of two dialysate sodium concentrations in hospitalized hemodialysis patients.
   Causland FRM, Ravi KS, Curtis KA, Kibbelaar ZA, et al · · 2022 · cited 6× · PMID 34792161 · DOI 10.1093/ndt/gfab329