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Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury
Phase 1, PHASE2 trial testing Bromocriptine 5 MG in Subarachnoid Hemorrhage in 47 participants. Completed in 2 November 2019.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 47 |
| Start date | 30 November 2018 |
| Primary completion | 2 November 2019 |
| Estimated completion | 2 November 2019 |
| Sites | 2 locations across United States |
University of California, San Francisco
Adults 18 to 100, any sex, with Subarachnoid Hemorrhage or Subdural Hematoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication.
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 37.8 | ± 0.5 |
| Bromocriptine and Acetaminophen | 37.7 | ± 0.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 12 | |
| Bromocriptine and Acetaminophen | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 2 | |
| Bromocriptine and Acetaminophen | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 8 | |
| Bromocriptine and Acetaminophen | 12 |
Time in minutes where the temperature is ≥ 38.3ºC during the 48 hours of control versus intervention administration.
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 216 | 85.5 – 1118 |
| Bromocriptine and Acetaminophen | 300 | 85.5 – 739 |
Time in minutes it took after medication administration for the temperature to reach \< 37.5ºC.
| Group | Value | 95% CI |
|---|---|---|
| Acetaminophen | 253.5 | 170.5 – 722.5 |
| Bromocriptine and Acetaminophen | 556 | 286.5 – 772.5 |
Time frame: 48 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Acetaminophen | Bromocriptine and Acetamin… |
|---|---|---|---|
| Hospitalization | General disorders | — | — |
| Reaction | System | Acetaminophen | Bromocriptine and Acetamin… |
|---|---|---|---|
| Blood pressure decrease | Cardiac disorders | — | — |
| Headache | General disorders | — | — |
| Hypotension required treatment | Cardiac disorders | — | — |
| Orthostasis | Cardiac disorders | — | — |
| Nausea | General disorders | — | — |
Most-reported serious reactions: Hospitalization.
Data from ClinicalTrials.gov NCT03496545 adverse events section.
The purpose of this study is to evaluate the antipyretic effect of bromocriptine in critically-ill patients with acute neurologic injury and fever from infectious and non-infectious etiologies.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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