Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Not Applicable

Completed

• Conditions: Intra-dialytic Hypotension
• Interventions: Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate); Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)

• Registration Number: NCT02145260
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-22
• Study Start: 2014-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-05-03
• Results First Submitted: 2022-08-09
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-02
• Last Update Submitted: 2022-10-02
• Results First Posted: 2022-10-31
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lower dialysate sodium	Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)	Dialysate sodium concentration of 138 mmol/L
Higher dialysate sodium	Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)	Dialysate sodium concentration of 142 mmol/L

Primary Outcome Measures

Name	Time	Method
Change in Intra-dialytic Decline in Systolic Blood Pressure	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.

Secondary Outcome Measures

Name	Time	Method
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	Cardiac injury biomarkers

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States