Intra-dialytic HypotensionNCT02145260
Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
A study testing Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) and Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) in people with Intra-dialytic Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-dialytic Hypotension
- What is being tested?
- Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) and Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 3 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HD (>90 days)
- Age ≥18y
- Informed consent
- First admission during study period.
Who cannot join
- 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
Show all 9Show fewer
- Acute stroke
- Institutionalized individuals
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
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.
Read more
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.
- Conditions
- Intra-dialytic Hypotension
- Being tested
- Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate), Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)
- Keywords
- Hemodialysis, Hypotension, Hospitalization
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| Lower dialysate sodium | Active comparator | Dialysate sodium concentration of 138 mmol/L Receives: Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) |
| Higher dialysate sodium | Experimental | Dialysate sodium concentration of 142 mmol/L Receives: Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Change in Pre-dialysis High-sensitivity Troponin I
Cardiac injury biomarkers
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start1 Jul 2014
- Primary completion31 Dec 2020
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intra-dialytic HypotensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Finnian McCausland, Brigham and Women's Hospital
- Investigators
- Finnian Mc Causland, MB, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145260
- Sponsor's protocol ID
- 2014P000629
- Status last verified
- Oct 2022
- First submitted
- 13 May 2014
- Last updated
- 31 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 39498822
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02145260
- Acronym / sponsor ID
- 2014P000629
- Conditions
- Intra-dialytic Hypotension
- Keywords
- Hemodialysis, Hypotension, Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower dialysate sodium | Active comparator | Drug: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)Dialysate sodium concentration of 138 mmol/L |
| Higher dialysate sodium | Experimental | Drug: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)Dialysate sodium concentration of 142 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic HD (>90 days)
- Age ≥18y
- Informed consent
- First admission during study period.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Lower dialysate sodium |
| Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)A higher dialysate sodium will be used in the experimental arm (142 mmol/L) | Drug | Higher dialysate sodium |
Primary outcome
Change in Intra-dialytic Decline in Systolic Blood Pressure
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
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.
1 secondary outcome
Change in Pre-dialysis High-sensitivity Troponin I
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39498822Marshall 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.
Related trials for Intra-dialytic Hypotension
Recruiting
Trial of Variable Dialysate Bicarbonate
Peri-dialytic Cardiac Rhythms, Intradialytic Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finnian Mc Causland, MB, MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) and Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) in people with Intra-dialytic Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intra-dialytic Decline in Systolic Blood Pressure (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02145260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.