Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

NCT ID: NCT02145260

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2021-05-03

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.

Conditions

Intra-dialytic Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lower dialysate sodium

Dialysate sodium concentration of 138 mmol/L

Group Type: ACTIVE_COMPARATOR

Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)

Intervention Type: DRUG

A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)

Higher dialysate sodium

Dialysate sodium concentration of 142 mmol/L

Group Type: EXPERIMENTAL

Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

Intervention Type: DRUG

A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Finnian McCausland

Assistant Professor of Medicine, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Finnian Mc Causland, MB, MMSc

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

Reference Type: DERIVED

PMID: 39498822 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P000629

Identifier Type: -

Identifier Source: org_study_id