Trial Outcomes & Findings for An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion (NCT NCT01645111)

Results Overview

The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

First 30 minutes of infusion

Results posted on

2015-02-18

Reasons for withdrawal
Measure	Clevidipine Clevidipine
Overall Study Did not require Clevidipine	15

An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion

Baseline characteristics by cohort
Measure	Clevidipine n=50 Participants Clevidipine
Age, Categorical <=18 years	47 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	14.6 years STANDARD_DEVIATION 3.2 • n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	26 Participants n=99 Participants
Region of Enrollment United States	50 participants n=99 Participants

Timeframe: First 30 minutes of infusion

The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg

Outcome measures
Measure	Clevidipine n=35 Participants Clevidipine
Time to Achieve Target MAP	9.2 minutes Standard Deviation 11.4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Nationwide Children's Hospital

Phone: 614-722-4200