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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower dialysate sodium | Active Comparator | Dialysate sodium concentration of 138 mmol/L |
|
| Higher dialysate sodium | Experimental | Dialysate sodium concentration of 142 mmol/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finnian Mc Causland, MB, MMSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39498822 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Higher Dialysate Sodium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 |
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| 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) |
|
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) |
| COMPLETED | Completed follow up |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Diabetes | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm Hg | 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 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Change in Pre-dialysis High-sensitivity Troponin I | Cardiac injury biomarkers | No measured due to sample storage issues | Posted | 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 |
|
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From randomization to maximum of 6 inpatient study sessions (two-week period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 69 | 1 | 69 | 28 | 69 |
| EG001 | 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) | 0 | 70 | 1 | 70 | 24 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NSTEMI non-ST segment elevation myocardial infarction | Cardiac disorders | Non-systematic Assessment | NSTEMI non-ST segment elevation myocardial infarction |
| |
| post-operative bleed | Blood and lymphatic system disorders | Non-systematic Assessment | Post-operative bleed |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
| ||
| Hypertension (>180 mmHg) | Cardiac disorders | Systematic Assessment |
| ||
| Chest pain/myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Other pain | Nervous system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Finnian Mc Causland | Brigham and Women's Hospital | 6177326432 | fmccausland@bwh.harvard.edu |
| Aug 9, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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