A Phase 2 interventional study of Mannitol (20%) and 0.9% saline in Intra-dialytic Hypotension, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-30.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Other
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 52 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 0.9% saline
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.
Drug: Mannitol (20%)
0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
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
Time frame: First three hemodialysis sessions (5 days)
July 2012 - Jul 2016
| Milestone | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) |
|---|---|---|
| Started | 27 | 25 |
| Completed | 25 | 25 |
| Not completed | 2 | 0 |
SBP decline during first three sessions
| mmHg | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) |
|---|---|---|
| Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | 19 ± 16 | 15 ± 11 |
Collected over 4 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Group: (0.9% Normal Saline) | 0/27 (0%) | 0/27 (0%) | 18/27 (66.7%) |
| Intervention: Intravenous Mannitol (20%) | 0/25 (0%) | 0/25 (0%) | 17/25 (68%) |
| Event | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) |
|---|---|---|
| HypertensionCardiac disorders | 10/27 | 9/25 |
| NauseaGastrointestinal disorders | 5/27 | 1/25 |
| Oxygen RequirementRespiratory, thoracic and mediastinal disorders | 2/27 | 4/25 |
| HypotensionCardiac disorders | 2/27 | 2/25 |
| Access issuesVascular disorders | 2/27 | 2/25 |
| Chest PainCardiac disorders | 0/27 | 2/25 |
| CrampsMusculoskeletal and connective tissue disorders | 2/27 | 1/25 |
| HeadacheNervous system disorders | 2/27 | 1/25 |
| ConfusionNervous system disorders | 2/27 | 1/25 |
| UTIInfections and infestations | 0/27 | 1/25 |
| Age, Continuous(years) | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) | Total |
|---|---|---|---|
| Mean | 57.7 ± 14.7 | 53.4 ± 17.4 | 55.6 ± 16 |
| Sex: Female, Male(Participants) | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 14 | 12 | 26 |
| Region of Enrollment(participants) | Placebo Group: (0.9% Normal Saline) | Intervention: Intravenous Mannitol (20%) | Total |
|---|---|---|---|
| United States | 27 | 25 | 52 |
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital