Trial Outcomes & Findings for Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury (NCT NCT03496545)

NCT ID: NCT03496545

Last Updated: 2021-06-24

Results Overview

Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: over 48 hours
• Results posted on: 2021-06-24

Participant Flow

Participant milestones

Measure	Acetaminophen Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Overall Study STARTED	21	26
Overall Study COMPLETED	20	24
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Bromocriptine For Fever Reduction in Acute Neurologic Injury

Baseline characteristics by cohort

Measure	Acetaminophen n=20 Participants Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=24 Participants Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Total n=44 Participants Total of all reporting groups
Age, Continuous	56.5 years n=5 Participants	60.5 years n=7 Participants	59.5 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	16 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: over 48 hours

Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication.

Outcome measures

Measure	Acetaminophen n=20 Participants Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=24 Participants Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Temperature Burden	37.8 Temperature in degrees Celsius Standard Deviation 0.5	37.7 Temperature in degrees Celsius Standard Deviation 0.6

SECONDARY outcome

Timeframe: Nursing assessment at every shift during 48 hour study period after first drug administration

Population: Safety documents were not filled out by nursing staff for 4 patients, 3 from the acetaminophen group and 1 from the bromocriptine and acetaminophen group.

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.

Outcome measures

Measure	Acetaminophen n=17 Participants Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=23 Participants Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache Decrease in blood pressure	12 Participants	17 Participants
Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache Nausea	2 Participants	3 Participants
Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache Headache	8 Participants	12 Participants

SECONDARY outcome

Timeframe: 48 hours

Time in minutes where the temperature is ≥ 38.3ºC during the 48 hours of control versus intervention administration.

Outcome measures

Measure	Acetaminophen n=20 Participants Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=24 Participants Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Total Time That Temperature is ≥ 38.3ºC	216 Minutes Interval 85.5 to 1118.0	300 Minutes Interval 85.5 to 739.0

SECONDARY outcome

Timeframe: 48 hours

Time in minutes it took after medication administration for the temperature to reach < 37.5ºC.

Outcome measures

Measure	Acetaminophen n=20 Participants Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=24 Participants Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Total Time to First Temperature < 37.5ºC	253.5 Minutes Interval 170.5 to 722.5	556 Minutes Interval 286.5 to 772.5

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Bromocriptine and Acetaminophen

Serious events: 1 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Measure	Acetaminophen n=21 participants at risk Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=26 participants at risk Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
General disorders Hospitalization	0.00% 0/21 • 48 hours	3.8% 1/26 • 48 hours

Other adverse events

Measure	Acetaminophen n=21 participants at risk Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.	Bromocriptine and Acetaminophen n=26 participants at risk Bromocriptine 5mg every 4 hours PO/NG/FT for 48 hours and acetaminophen 650mg every 4 hours PO/NG/FT for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.
Cardiac disorders Blood pressure decrease	57.1% 12/21 • 48 hours	65.4% 17/26 • 48 hours
Cardiac disorders Hypotension required treatment	23.8% 5/21 • 48 hours	34.6% 9/26 • 48 hours
Cardiac disorders Orthostasis	19.0% 4/21 • 48 hours	19.2% 5/26 • 48 hours
General disorders Headache	38.1% 8/21 • 48 hours	46.2% 12/26 • 48 hours
General disorders Nausea	9.5% 2/21 • 48 hours	11.5% 3/26 • 48 hours

Additional Information

Judy Ch'ang, MD

Weill Cornell Medicine

Phone: (212) 746-2596

Email: jhc9010@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place