Trial · NCT01520207
Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
NCT01520207, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2017-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension. Trials, record NCT01520207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01520207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension
- NCT number
- NCT01520207
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Intra-dialytic Hypotension
- Interventions
- Mannitol (20%), 0.9% saline
- First posted
- 2012-01-27
- Last updated
- 2019-01-30
- Results first posted
- 2017-10-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | First three hemodialysis sessions (5 days) | SBP decline during first three sessions |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | First three hemodialysis sessions (5 days) | SBP decline | mmHg | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | Placebo Group: (0.9% Normal Saline) | 19 | Standard Deviation 16 | mmHg | |
| Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions. | Intervention: Intravenous Mannitol (20%) | 15 | Standard Deviation 11 | mmHg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Group: (0.9% Normal Saline) | 27 | |
| Overall Study | STARTED | Intervention: Intravenous Mannitol (20%) | 25 | |
| Overall Study | COMPLETED | Placebo Group: (0.9% Normal Saline) | 25 | |
| Overall Study | COMPLETED | Intervention: Intravenous Mannitol (20%) | 25 | |
| Overall Study | NOT COMPLETED | Placebo Group: (0.9% Normal Saline) | 2 | |
| Overall Study | NOT COMPLETED | Intervention: Intravenous Mannitol (20%) | 0 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cramps | Musculoskeletal and connective tissue disorders | Placebo Group: (0.9% Normal Saline) | 2 | 27 | 2 |
| other | Cramps | Musculoskeletal and connective tissue disorders | Intervention: Intravenous Mannitol (20%) | 1 | 25 | 2 |
| other | Hypertension | Cardiac disorders | Placebo Group: (0.9% Normal Saline) | 10 | 27 | 15 |
| other | Hypertension | Cardiac disorders | Intervention: Intravenous Mannitol (20%) | 9 | 25 | 15 |
| other | Hypotension | Cardiac disorders | Placebo Group: (0.9% Normal Saline) | 2 | 27 | 4 |
| other | Hypotension | Cardiac disorders | Intervention: Intravenous Mannitol (20%) | 2 | 25 | 2 |
| other | Headache | Nervous system disorders | Placebo Group: (0.9% Normal Saline) | 2 | 27 | 3 |
| other | Headache | Nervous system disorders | Intervention: Intravenous Mannitol (20%) | 1 | 25 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo Group: (0.9% Normal Saline) | 5 | 27 | 5 |
| other | Nausea | Gastrointestinal disorders | Intervention: Intravenous Mannitol (20%) | 1 | 25 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Group: (0.9% Normal Saline) | 0 | 27 |
| Total, all-cause mortality | Intervention: Intravenous Mannitol (20%) | 0 | 25 |
| Total, other adverse events | Placebo Group: (0.9% Normal Saline) | 18 | 27 |
| Total, other adverse events | Intervention: Intravenous Mannitol (20%) | 17 | 25 |
| Total, serious adverse events | Placebo Group: (0.9% Normal Saline) | 0 | 27 |
| Total, serious adverse events | Intervention: Intravenous Mannitol (20%) | 0 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo Group: (0.9% Normal Saline) vs Intervention: Intravenous Mannitol (20%): deaths from any cause | Trial comparisons |
| Placebo Group: (0.9% Normal Saline) vs Intervention: Intravenous Mannitol (20%): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01520207
GET https://conductscience.org/api/trials/v1/NCT01520207/events?page=2