Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury (NCT03496545) | Clinical Trial Compass
CompletedPhase 1/2
Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury
United States47 participantsStarted 2018-11-30
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 (\< 26 weeks), evidence of coagulation abnormality: international normalized ratio (INR) ≥ 2; evidence of liver damage: alanine aminotransferase (ALT) of 10 x normal value; and any degree of mental status alteration
* currently being treated with intra or extravascular therapeutic hypothermia - or where therapeutic hypothermia treatment is anticipated during study period
* hyperthermic syndromes: heat stroke, evidence of thyrotoxicosis, malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia
* administration of acetaminophen or acetaminophen containing medications within 9 hours prior to fever presentation
* administration of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours prior to fever presentation or aspirin \> 300mg less tha…