Intra-dialytic Hypotension
Conditions
Keywords
Hemodialysis, Hypotension, Hospitalization
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.
Interventions
DRUGLower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)
A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
DRUGHigher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
3 patients in the lower dialysate sodium arm and 2 patients in the higher dialysate sodium arm were discharged prior to the first study session.
Participants by arm
| Arm | Count |
|---|---|
| Lower Dialysate Sodium Dialysate sodium concentration of 138 mmol/L
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) | 69 |
| Higher Dialysate Sodium Dialysate sodium concentration of 142 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) | 70 |
| Total | 139 |
Baseline characteristics
| Characteristic | Lower Dialysate Sodium | Higher Dialysate Sodium | Total |
|---|---|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 15 | 59.5 years STANDARD_DEVIATION 14.5 |
| Diabetes | 36 Participants | 39 Participants | 75 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 25 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) White | 38 Participants | 34 Participants | 72 Participants |
| Region of Enrollment United States | 69 participants | 70 participants | 139 participants |
| Sex: Female, Male Female | 26 Participants | 34 Participants | 60 Participants |
| Sex: Female, Male Male | 43 Participants | 36 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 70 |
| other Total, other adverse events | 28 / 69 | 24 / 70 |
| serious Total, serious adverse events | 1 / 69 | 1 / 70 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lower Dialysate Sodium | Change in Intra-dialytic Decline in Systolic Blood Pressure | 26 mm Hg | Standard Deviation 16 |
| Higher Dialysate Sodium | Change in Intra-dialytic Decline in Systolic Blood Pressure | 23 mm Hg | Standard Deviation 16 |
Secondary
Change in Pre-dialysis High-sensitivity Troponin I
Cardiac injury biomarkers
Time frame: 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
Population: No measured due to sample storage issues