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Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

NCT02145260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-10-31

Study results available
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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

  • Intra-dialytic Hypotension

Interventions

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)

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)

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Finnian Mc Causland, MB, MMSc · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-01
Primary Completion
2020-12-31
Completion
2021-05-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145260 on ClinicalTrials.gov