Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Intra-dialytic Hypotension Clinical Trial

Official title:

Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145260
• Other study ID #: 2014P000629
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: May 3, 2021

Study information

• Verified date: October 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 3, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intra-dialytic Hypotension

Intervention

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)
• Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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