Phase 2
N=47
Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury
Subarachnoid Hemorrhage · Subdural Hematoma · Traumatic Brain Injury · Ischemic Stroke · Fever
Bottom Line
View on ClinicalTrials.gov: NCT03496545 ↗Enrolled (actual)
47
Serious AEs
2.1%
Results posted
Jun 2021
Primary outcome: Primary: Temperature Burden — 37.8; 37.7 Temperature in degrees Celsius
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bromocriptine 5 MG (Drug); Acetaminophen 650 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Temperature Burden |
37.8; 37.7 | — |
| SECONDARY Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache |
12; 17; 2; 3; 8; 12 | — |
| SECONDARY Total Time That Temperature is ≥ 38.3ºC |
216; 300 | — |
| SECONDARY Total Time to First Temperature < 37.5ºC |
253.5; 556 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- age ≥18 years old
- weight ≥ 40 kg
- one reading of body temperature ≥ 38.3 ºC
- diagnosis of subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury, subdural hematoma, or ischemic stroke
- admission to the Intensive Care Unit at UCSF Medical Center or Zuckerberg San Francisco General Hospital.
Exclusion Criteria
- bromocriptine or acetaminophen hypersensitivity or allergy
- known contraindication to bromocriptine- known ergot alkaloid hypersensitivity, known history of syncopal migraine
- contraindication to nasogastric tube or swallowing pills
- current diagnosis of acute liver failure, acute liver injury, or prior diagnosis of cirrhosis. acute presentation ( 300mg less than 1 hour prior to fever presentation.
- pregnancy
- extracorporeal blood circuit therapies: replacement therapy, extracorporeal life support (ventricular assist device, extracorporeal membrane oxygenation) during study period
- anticipated ICU stay < 48 hours'
- creatinine clearance ≤ 30
- severe cardiovascular disease (especially unstable angina or severe valvular disease)
- patients already taking bromocriptine for other indications
Data sourced from ClinicalTrials.gov (NCT03496545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.