Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury

Completed · Phase 1/Phase 2

Conditions studied: Subarachnoid Hemorrhage, Subdural Hematoma, Traumatic Brain Injury, Ischemic Stroke, Fever, Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT03496545

Run by

University of California, San Francisco

People needed

47

Starts

2018-11-30

Expected to finish

2019-11-02

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States
• University of California, San Francisco Medical Center - Parnassus — San Francisco, California, United States

Full record on ClinicalTrials.gov

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