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

• ClinicalTrials.gov Identifier: NCT01645111
• Recruitment Status: Completed
• First Posted: July 20, 2012
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015
• Sponsor: Nationwide Children's Hospital
• Information provided by (Responsible Party): Joseph D. Tobias, Nationwide Children's Hospital

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Neuromuscular Scoliosis
• Intervention: Drug: Clevidipine
• Enrollment: 50

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Clevidipine
Arm/Group Description	Clevidipine
Period Title: Overall Study
Started	50
Completed	35
Not Completed	15
Reason Not Completed
Did not require Clevidipine	15

Baseline Characteristics

Arm/Group Title		Clevidipine
Arm/Group Description		Clevidipine
Overall Number of Baseline Participants		50
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants
	<=18 years	47 94.0%
	Between 18 and 65 years	3 6.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	50 participants
		14.6 (3.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	50 participants
	Female	24 48.0%
	Male	26 52.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	50 participants
		50

Outcome Measures

1. Primary Outcome

Title	Time to Achieve Target MAP
Description	The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg
Time Frame	First 30 minutes of infusion

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Clevidipine
Arm/Group Description:	Clevidipine
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: minutes
	9.2 (11.4)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Clevidipine
Arm/Group Description	Clevidipine
All-Cause Mortality
	Clevidipine
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Clevidipine
	Affected / at Risk (%)
Total	0/50 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Clevidipine
	Affected / at Risk (%)
Total	0/50 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Joseph D. Tobias, MD
• Organization: Nationwide Children's Hospital
• Phone: 614-722-4200
• EMail: Joseph.Tobias@nationwidechildrens.org

• Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT01645111
• Other Study ID Numbers: IRB12-00261
• First Submitted: June 8, 2012
• First Posted: July 20, 2012
• Results First Submitted: February 3, 2015
• Results First Posted: February 18, 2015
• Last Update Posted: February 18, 2015