Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Study Overview
=================
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.

Official Title
-----------------
Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Conditions
-----------------
Intra-dialytic Hypotension

Intervention / Treatment
-----------------
* Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
* Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lower dialysate sodium<br>Dialysate sodium concentration of 138 mmol/L | Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)<br>* A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)<br>|
| Experimental: Higher dialysate sodium<br>Dialysate sodium concentration of 142 mmol/L | Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)<br>* A higher dialysate sodium will be used in the experimental arm (142 mmol/L)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pre-dialysis High-sensitivity Troponin I | Cardiac injury biomarkers | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Hypotension, Hospitalization