Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury

• Status: Completed
• Trial end date: 2019-11-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Acetaminophen; Bromocriptine

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 (< 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 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