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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannitol (20%) | Drug | 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | First three hemodialysis sessions (5 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sushrut S Waikar, MD, MPH | Brigham and Women's Hospital, Harvard Medical School | Principal Investigator |
| Finnian R 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 |
|---|---|---|---|
| 37875429 | Derived | 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. | |
| 31040088 | Derived | Mc 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. |
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July 2012 - Jul 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group: (0.9% Normal Saline) | 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. 0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment |
| FG001 | Intervention: Intravenous 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. Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group: (0.9% Normal Saline) | 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. 0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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 | SBP decline | Posted | Mean | Standard Deviation | mmHg | First three hemodialysis sessions (5 days) |
|
4 years
Adverse events were monitored for all participants during their HD sessions
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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 | Placebo Group: (0.9% Normal Saline) | 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. 0.9% saline: 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Cramps |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Finnian Mc Causland | Brigham and Women's Hosptial | 6177326432 | fmccausland@partners.org |
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| 0.9% saline | Drug | 1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment |
|
| BG001 |
| Intervention: Intravenous 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. Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
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. Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) |
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 18 |
| 27 |
| EG001 | Intervention: Intravenous 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. Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session) | 0 | 25 | 0 | 25 | 17 | 25 |
| Hypertension | Cardiac disorders | Non-systematic Assessment | HTN |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| UTI | Infections and infestations | Non-systematic Assessment |
|
| Access issues | Vascular disorders | Non-systematic Assessment |
|
| Oxygen Requirement | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |