Intra-dialytic HypotensionPhase 2NCT01520207
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
A Phase 2 study testing Mannitol (20%) and 0.9% saline in people with Intra-dialytic Hypotension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. 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?
- Mannitol (20%) and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2018
- Phase
- Phase 2
- 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
- Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent
Who cannot join
- Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
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: Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.
Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.
- Conditions
- Intra-dialytic Hypotension
- Being tested
- Mannitol (20%), 0.9% saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol (20%)Drug
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
0.9% salineDrug
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo group: (0.9% normal saline) | Placebo comparator | 0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session. Receives: Drug: 0.9% saline |
| Intervention: intravenous mannitol (20%) | Active comparator | Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session. Receives: Drug: Mannitol (20%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
SBP decline during first three sessions
Measured: First three hemodialysis sessions (5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2016
- Study completionDec 2018
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 (2)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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushrut S Waikar, Brigham and Women's Hospital
- Investigators
- Sushrut S Waikar, MD, MPH, Principal investigator, Brigham and Women's Hospital, Harvard Medical SchoolFinnian R Mc Causland, MB, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520207
- Sponsor's protocol ID
- NCT01520207
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2012
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Curtis KA, Waikar SS, Mc Causland FR. Higher NT-proBNP levels and the risk of intradialytic hypotension at hemodialysis initiation. Hemodial Int. 2024 Jan;28(1):77-84. doi: 10.1111/hdi.13125. Epub 2023 Oct 24.
PubMed 37875429Mc Causland FR, Claggett B, Sabbisetti VS, Jarolim P, Waikar SS. Hypertonic Mannitol for the Prevention of Intradialytic Hypotension: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Oct;74(4):483-490. doi: 10.1053/j.ajkd.2019.03.415. Epub 2019 Apr 27.
PubMed 31040088
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Intravenous Mannitol During Hemodialysis Initiation to Reduce the Occurrence of Intra-dialytic Hypotension.
- ClinicalTrials.gov ID
- NCT01520207
- Acronym / sponsor ID
- NCT01520207
- Conditions
- Intra-dialytic Hypotension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Jan 2012 (estimated)
- Results
- Posted 19 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney failure can result from a variety of conditions and can be temporary or permanent. Hemodialysis is available as a replacement treatment to perform the work that the kidneys normally do. However, the dialysis procedure can be associated with rapid changes in the composition of the blood - this may lead to changes in blood pressure and in turn reduced blood supply to important parts of the body. We aim to investigate if giving a medicine (called mannitol) during dialysis may be able to reduce the frequency of these low blood pressure events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group: (0.9% normal saline) | Placebo comparator | Drug: 0.9% saline0.9% saline will be administered (IV) during the hemodialysis session at 1.25mL/kg/hour (max 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session. |
| Intervention: intravenous mannitol (20%) | Active comparator | Drug: Mannitol (20%)Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent
Key exclusion criteria (1 listed)
- Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol
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 |
|---|---|---|
| Mannitol (20%)0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) | Drug | Intervention: intravenous mannitol (20%) |
| 0.9% saline1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment | Drug | Placebo group: (0.9% normal saline) |
Primary outcome
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.
Time frame: First three hemodialysis sessions (5 days)
SBP decline during first three sessions
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37875429Curtis KA, Waikar SS, Mc Causland FR. Higher NT-proBNP levels and the risk of intradialytic hypotension at hemodialysis initiation. Hemodial Int. 2024 Jan;28(1):77-84. doi: 10.1111/hdi.13125. Epub 2023 Oct 24.
- Derived from this study: PubMed 31040088Mc Causland FR, Claggett B, Sabbisetti VS, Jarolim P, Waikar SS. Hypertonic Mannitol for the Prevention of Intradialytic Hypotension: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Oct;74(4):483-490. doi: 10.1053/j.ajkd.2019.03.415. Epub 2019 Apr 27.
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.
Sushrut S Waikar, MD, MPH principal investigator
Brigham and Women's Hospital, Harvard Medical School
Finnian R 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 Phase 2 study testing Mannitol (20%) and 0.9% saline 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 1 inclusion and 1 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 30 Jan 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2017). 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?
Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. (time frame: First three hemodialysis sessions (5 days)). 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 NCT01520207, which also lists 2 linked publications.
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 30 Jan 2019.