Pediatric Perioperative Blood Pressure Management Clinical Trial
— PIONEEROfficial title:
Open Label Study to Assess the Efficacy, Safety and Dosing of Clevidipine in Pediatric Patients Undergoing Surgery
| Verified date | May 2024 |
| Source | Chiesi Farmaceutici S.p.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the efficacy, safety and dosing of an intravenous (IV) infusion of clevidipine for blood pressure (BP) management in pediatric participants in the perioperative setting.
| Status | Terminated |
| Enrollment | 22 |
| Est. completion date | February 20, 2024 |
| Est. primary completion date | February 20, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 17 Years |
| Eligibility | Inclusion Criteria: - Less than 18 years of age - Written informed consent obtained before initiation of any study-related procedures - The enrolling physician determines that the participant will likely require a 15% reduction in BP during the perioperative course - Intra-arterial line is available for blood pressure monitoring - Surgical procedure requiring a minimum of 1 hour of anesthesia, in which IV antihypertensive therapy to control BP for at least 30 minutes is anticipated Exclusion Criteria: - Administration of an IV or oral antihypertensive agent within 2 hours prior to study drug administration - Congenital heart disease described as single ventricle - Evidence of liver failure, severe liver disease, pulmonary disease (e.g. uncontrolled asthma), hyperlipidemia, lipoid nephrosis, lipid dysfunction or acute pancreatitis - Allergy to soya bean oil or egg lecithin - Known to be intolerant to calcium channel blockers - Hemophilia or blood coagulation disorders - Any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures - Clinically significant abnormal physical findings at the screening evaluation - Any serious surgical or medical condition which, in the opinion of the investigator, is likely to interfere with study procedures or with the pharmacokinetics or pharmacodynamics of the study drug - Participant is terminally ill (death likely to occur within 48 hours) - Use of Methylphenidate, calcium channel blockers, Aripiprazole and other atypical anti- psychotics and antihypertensives used for BP control within 2 hours prior to study drug initiation - Positive serum or urine pregnancy test for any female of child bearing potential - Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment - Participants who, for any reason, are deemed by the Investigator to be inappropriate for this study - Participant is a relative of the Investigator or his/her deputy, research assistant, pharmacist, study coordinator, other staff directly involved in the conduct of the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Nationwide Children's Hospital | Columbus | Ohio |
| United States | Stanford Medical Center | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Chiesi Farmaceutici S.p.A. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy: Median time to attain the initial pre-specified target SBP range (=20 mm Hg and = 40 mm Hg apart) | During the first 30 minutes of clevidipine infusion | ||
| Primary | Efficacy: Dose to attain the initial pre-specified target SBP range (=20 mm Hg and = 40 mm Hg apart) | During the first 30 minutes of clevidipine infusion | ||
| Primary | Efficacy: Percentage of participants achieving the initial pre-specified target SBP range | During the first 30 minutes of clevidipine infusion | ||
| Primary | Pharmacology: Pharmacokinetic variables [half-life, Area Under the Curve (AUC), volume of distribution, clearance] established by noncompartmental analysis or sparse population methodology | Through 8 hours post-termination of clevidipine infusion (minimum of 9 hours up to a maximum of approximately 4 1/2 days) | ||
| Primary | Pharmacology: Pharmacodynamic variables (relationship between change from baseline in SBP versus blood concentration and infusion rate) | Duration of clevidipine infusion (minimum of 30 minutes up to a maximum 96 hours) | ||
| Primary | Safety: Safety of a prolonged infusion of clevidipine assessed through clinical laboratory parameters, adverse events and serious adverse events (SAEs) | Through 7 days post-termination of clevidipine infusion (minimum of approximately 7 1/2 days up to a maximum of approximately 11 1/2 days) | ||
| Secondary | Efficacy: The percentage of participants who reach the initial pre-specified target SBP range without falling below the lower limit of the pre-specified target range | During the first 30 minutes of clevidipine infusion | ||
| Secondary | Efficacy: The percentage of participants in whom the SBP falls below the lower limit of the pre-specified target range at any time | During the first 30 minutes of clevidipine infusion | ||
| Secondary | Efficacy: The percentage of participants in whom the SBP falls below the lower limit of the pre-specified target range at any time during the entire study drug treatment period | Minimum of 30 minutes up to a maximum of 96 hours | ||
| Secondary | Efficacy: The percentage of participants in whom the SBP is within target range at each hour after the first 30 minutes of clevidipine infusion | 30 minutes post-clevidipine infusion through termination of clevidipine infusion (minimum of <1 minute up to a maximum of 95 1/2 hours) | ||
| Secondary | Efficacy: The percentage of participants who require rescue therapy (i.e. receive any alternative IV antihypertensive drug) at any time during the study drug treatment period | Minimum of 30 minutes up to a maximum of 96 hours | ||
| Secondary | Efficacy: Percent change in SBP from baseline at each time point | Every 1.5 minutes during the first 30 minutes of clevidipine infusion (approximately 20 measurements) | ||
| Secondary | Efficacy: Percent change from baseline in SBP | At each hour after 30 minutes post-clevidipine infusion through termination of clevidipine infusion (up to a maximum of 96 measurements) | ||
| Secondary | Efficacy: Percent change from baseline in SBP over the first 8 hours post-study drug termination | During the first 8 hours after termination of clevidipine infusion | ||
| Secondary | Efficacy: Percent change from baseline in heart rate | During the first 30 minutes of clevidipine infusion | ||
| Secondary | Efficacy: Percent change from baseline in heart rate | 30 minutes post-clevidipine infusion through termination of clevidipine infusion (minimum of <1 minute up to a maximum of 95 1/2 hours) |