NCT01645111

Brief Summary

The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 18, 2015

Completed
Last Updated

February 18, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

June 8, 2012

Results QC Date

February 3, 2015

Last Update Submit

February 3, 2015

Conditions

Neuromuscular Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Time to Achieve Target MAP

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

    First 30 minutes of infusion

Study Arms (1)

Clevidipine

ACTIVE COMPARATOR
Drug: Clevidipine

Interventions

ClevidipineDRUG
Clevidipine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Spinal fusion for neuromuscular scoliosis.

You may not qualify if:

  • Allergy to dihydropyridine calcium channel antagonists
  • Allergy to soy or eggs
  • Non-neuromuscular causes of scoliosis
  • Disorders of lipid metabolism (clevidipine is in a lipid base)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

clevidipine

Results Point of Contact

Title
Joseph D. Tobias, MD
Organization
Nationwide Children's Hospital
Joseph.Tobias@nationwidechildrens.org
614-722-4200

Study Officials

  • Joseph Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

June 8, 2012

First Posted

July 20, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 18, 2015

Results First Posted

February 18, 2015

Record last verified: 2015-02

Locations

US(1)