Trial Outcomes & Findings for A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients (NCT NCT00952081)
NCT ID: NCT00952081
Last Updated: 2015-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
intraoperatively and 90 min after surgery
Results posted on
2015-02-09
Participant Flow
Patients scheduled for intracranial surgery were prospectively enrolled after giving consent. Clevidipine (0.5 mg/mL in 20% lipid solution, which was to be initiated at 10 mg/h and titrated to effect) was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
Participant milestones
| Measure |
Clevidipine,Brain Tumor,Hypertension
Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Evaluate Efficacy and Safety of Clevidipine in Neurosurgical Patients
Baseline characteristics by cohort
| Measure |
Clevidipine,Brain Tumor,Hypertension
n=22 Participants
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 14.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intraoperatively and 90 min after surgeryOutcome measures
| Measure |
Clevidipine,Brain Tumor,Hypertension
n=22 Participants
21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
|
|---|---|
|
The Primary Endpoint of This Trial is the Proportion of Patients Who Did Not Require Rescue Antihypertensive Medication to Maintain SBP Below 130 mmHg (i.e. Clevidipine is a Sole Antihypertensive Agent Used for Blood Pressure Control)
|
21 participants
|
Adverse Events
Clevidipine,Brain Tumor,Hypertension
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place