Trial Outcomes & Findings for Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department (NCT NCT00765648)

Results Overview

Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

226 participants

Primary outcome timeframe

30 minutes after initiation of therapy

Results posted on

2015-01-06

Participant Flow

Eligible patients had 2 systolic blood pressures(BP) measures \> 180 mmHg at least 10 minutes apart, and no contraindications.Emergency room setting.

Participant milestones

Participant milestones
Measure	Nicardipine Dosing Was 5 mg/Hour nicardipine intravenous	Bolus Labetalol Began at 20 mg Over 2 Minutes Labetalol
Overall Study STARTED	110	116
Overall Study COMPLETED	109	114
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nicardipine Dosing Was 5 mg/Hour n=110 Participants nicardipine intravenous	Bolus Labetalol Began at 20 mg Over 2 Minutes n=116 Participants Labetalol	Total n=226 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	81 Participants n=5 Participants	98 Participants n=7 Participants	179 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	18 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	57 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment United States	110 participants n=5 Participants	116 participants n=7 Participants	226 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes after initiation of therapy

Population: Intent to treat cohort.

Percentage of subjects achieving a pre-defined target systolic blood pressure (BP) range defined as a systolic blood pressure that is within +/- 20 mmHg of the target as established by the investigator.

Outcome measures

Outcome measures
Measure	Nicardipine n=109 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=114 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Percentage of Subjects Achieving a Pre-defined Target Systolic Blood Pressure (BP) Within 30 Minutes.	91.7 percentage of participants	82.5 percentage of participants

SECONDARY outcome

Timeframe: 30 minutes

Calculated as the mean (± standard deviation) number of titrations over 30 minutes for each treatment group

Outcome measures

Outcome measures
Measure	Nicardipine n=109 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=114 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Average Number of Dose Titrations Within 30 Minutes	2.2 number of titrations Standard Deviation 1	1.3 number of titrations Standard Deviation 0.97

SECONDARY outcome

Timeframe: 6 hours

Population: these are the correct participant numbers for this secondary analysis

Median number of hours from hospital admission until Emergency Department(ED)disposition

Outcome measures

Outcome measures
Measure	Nicardipine n=109 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=115 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Emergency Department(ED)Time to Disposition Decision	4.6 hours Interval 3.5 to 6.6	4.6 hours Interval 3.1 to 7.6

SECONDARY outcome

Timeframe: 6 hours

Population: these are the correct participant numbers for this secondary analysis

Treatment failure is defined as admission to the hospital or observation unit for BP management

Outcome measures

Outcome measures
Measure	Nicardipine n=109 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=115 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Treatment Failure	43.1 percentage of participants	37.4 percentage of participants

SECONDARY outcome

Timeframe: 6 hours

The percent of subjects requiring the use of intravenous rescue medications

Outcome measures

Outcome measures
Measure	Nicardipine n=110 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=116 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Subjects Requiring the Use of Intravenous Rescue Medications	15.5 percentage of participants	22.4 percentage of participants

SECONDARY outcome

Timeframe: 6 hours

Population: these are the correct participant numbers for this secondary analysis

The median transition time (in hours) to oral medication

Outcome measures

Outcome measures
Measure	Nicardipine n=96 Participants Nicardipine was administered at 5mg/hour and increased every 5 minutes by 2.5 mg/hour until the target systolic blood pressure (SBP) range is reached or maximum of 15mg/hour is achieved.	Labetalol n=85 Participants Labetalol is given intravenous bolus starting with 20mg over 2 minutes, which is repeated at 20, 40, or 80mg injections every 10 minutes until the target systolic blood pressure (SBP) range is reached or a maximum of 300mg is administered.
Transition Time to Oral Medication	4.9 hours Interval 1.4 to 10.9	6.4 hours Interval 2.2 to 16.5

Adverse Events

Nicardipine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Labetalol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicardipine n=110 participants at risk Nicardipine dosing was 5 mg/hour	Labetalol n=116 participants at risk Bolus Labetalol began at 20 mg over 2 minutes
Cardiac disorders Elevated cardiac biomarkers	0.91% 1/110 • Number of events 1 • Emergency Room visit Elevated cardiac markers	0.00% 0/116 • Emergency Room visit Elevated cardiac markers

Additional Information

Frank Peacock MD

Cleveland Clinic

Phone: (216) 445-4557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60