Trial · NCT03496545
Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury
NCT03496545, Phase 1, Phase 2, Completed, University of California, San Francisco; results first posted 2021-06-24
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury. Trials, record NCT03496545. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03496545
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury
- NCT number
- NCT03496545
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Subarachnoid Hemorrhage, Subdural Hematoma, Traumatic Brain Injury, Ischemic Stroke, Fever, Intracerebral Hemorrhage
- Interventions
- Bromocriptine 5 MG, Acetaminophen 650 MG
- First posted
- 2018-04-12
- Last updated
- 2021-06-24
- Results first posted
- 2021-06-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Temperature Burden | over 48 hours | Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication. |
| Secondary | Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Nursing assessment at every shift during 48 hour study period after first drug administration | Episodes of symptomatic hypotension, including decrease in supine systolic and diastolic pressures of greater than 20mm and 10mm Hg respectively with patient reported accompanying symptoms of light headedness or dizziness and incidence of nausea and headache. |
| Secondary | Total Time That Temperature is ≥ 38.3ºC | 48 hours | Time in minutes where the temperature is ≥ 38.3ºC during the 48 hours of control versus intervention administration. |
| Secondary | Total Time to First Temperature < 37.5ºC | 48 hours | Time in minutes it took after medication administration for the temperature to reach \< 37.5ºC. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Temperature Burden | over 48 hours | Temperature in degrees Celsius | MEAN | |
| SECONDARY | Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Nursing assessment at every shift during 48 hour study period after first drug administration | Safety documents were not filled out by nursing staff for 4 patients, 3 from the acetaminophen group and 1 from the bromocriptine and acetaminophen group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Time That Temperature is ≥ 38.3ºC | 48 hours | Minutes | MEAN | |
| SECONDARY | Total Time to First Temperature < 37.5ºC | 48 hours | Minutes | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Temperature Burden | Acetaminophen | 37.8 | Standard Deviation 0.5 | Temperature in degrees Celsius | |
| Temperature Burden | Bromocriptine and Acetaminophen | 37.7 | Standard Deviation 0.6 | Temperature in degrees Celsius | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Acetaminophen | Decrease in blood pressure | 12 | Participants | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Bromocriptine and Acetaminophen | Decrease in blood pressure | 17 | Participants | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Acetaminophen | Nausea | 2 | Participants | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Bromocriptine and Acetaminophen | Nausea | 3 | Participants | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Acetaminophen | Headache | 8 | Participants | |
| Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache | Bromocriptine and Acetaminophen | Headache | 12 | Participants | |
| Total Time That Temperature is ≥ 38.3ºC | Acetaminophen | 216 | Inter-Quartile Range 85.5 to 1118 | Minutes | |
| Total Time That Temperature is ≥ 38.3ºC | Bromocriptine and Acetaminophen | 300 | Inter-Quartile Range 85.5 to 739 | Minutes |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetaminophen | 21 | |
| Overall Study | STARTED | Bromocriptine and Acetaminophen | 26 | |
| Overall Study | COMPLETED | Acetaminophen | 20 | |
| Overall Study | COMPLETED | Bromocriptine and Acetaminophen | 24 | |
| Overall Study | NOT COMPLETED | Acetaminophen | 1 | |
| Overall Study | NOT COMPLETED | Bromocriptine and Acetaminophen | 2 |
Source ClinicalTrials.gov
Adverse events12
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 | Blood pressure decrease | Cardiac disorders | Acetaminophen | 12 | 21 | |
| other | Blood pressure decrease | Cardiac disorders | Bromocriptine and Acetaminophen | 17 | 26 | |
| other | Hypotension required treatment | Cardiac disorders | Acetaminophen | 5 | 21 | |
| other | Hypotension required treatment | Cardiac disorders | Bromocriptine and Acetaminophen | 9 | 26 | |
| other | Orthostasis | Cardiac disorders | Acetaminophen | 4 | 21 | |
| other | Orthostasis | Cardiac disorders | Bromocriptine and Acetaminophen | 5 | 26 | |
| other | Headache | General disorders | Acetaminophen | 8 | 21 | |
| other | Headache | General disorders | Bromocriptine and Acetaminophen | 12 | 26 | |
| other | Nausea | General disorders | Acetaminophen | 2 | 21 | |
| other | Nausea | General disorders | Bromocriptine and Acetaminophen | 3 | 26 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acetaminophen | 0 | 21 |
| Total, all-cause mortality | Bromocriptine and Acetaminophen | 1 | 26 |
| Total, other adverse events | Acetaminophen | 17 | 21 |
| Total, other adverse events | Bromocriptine and Acetaminophen | 23 | 26 |
| Total, serious adverse events | Acetaminophen | 0 | 21 |
| Total, serious adverse events | Bromocriptine and Acetaminophen | 1 | 26 |
Source ClinicalTrials.gov
Papers29
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 |
|---|---|
| Acetaminophen vs Bromocriptine and Acetaminophen: deaths from any cause | Trial comparisons |
| Acetaminophen vs Bromocriptine and Acetaminophen: 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/NCT03496545
GET https://conductscience.org/api/trials/v1/NCT03496545/papers?page=2