Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

NCT02145260 | Completed Results

• 1 other identifier: 2014P000629
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

Hemodialysis; Hypotension; Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (1)

• Change in Pre-dialysis High-sensitivity Troponin I

  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

Study Arms (2)

Lower dialysate sodium

ACTIVE COMPARATOR

Dialysate sodium concentration of 138 mmol/L

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

Higher dialysate sodium

EXPERIMENTAL

Dialysate sodium concentration of 142 mmol/L

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

Interventions

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

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

Lower dialysate sodium

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

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

Higher dialysate sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 39498822 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Finnian Mc Causland
• Organization: Brigham and Women's Hospital

fmccausland@bwh.harvard.edu

6177326432

Study Officials

• Finnian Mc Causland, MB, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 22, 2014
• Study Start: July 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: May 3, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-10

Locations

US (1)