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Sponsors and Collaborators: |
National Institute of Child Health and Human Development (NICHD) Stanford University Duke University |
Information provided by: | National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00135668 |
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.
Condition | Intervention | Phase |
Hypotension |
Drug: nitroprusside |
Phase II |
MedlinePlus related topics: | Low Blood Pressure |
ChemIDplus related topics: | Sodium nitroprusside Nitroprusside |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase 2 Multicenter, Randomized, Double-Blind, Parallel Group, Dose-Ranging, Effect-Controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside in Pediatric Subjects |
Enrollment: | 203 |
Study Start Date: | August 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Nitroprusside infusion 0.3 mcg/kg/min
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Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
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2: Active Comparator
nitroprusside infusion 1 mcg/kg/min
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Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
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3: Active Comparator
nitroprusside infusion 2 mcg/kg/min
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Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
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4: Active Comparator
nitroprusside 3 mcg/kg/min
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Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
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The trial is a multicenter randomized, double-blind, parallel group, dose-ranging, effect-controlled study examining the effects of sodium nitroprusside in pediatric subjects requiring relative hypotension during a surgical or medical procedure. The goal is to establish the starting and maximum infusion rates that afford optimum blood pressure control in children and a safe dosing regimen in children. The objective is to describe the relationship between the infusion rate of nitroprusside and changes in blood pressure.
The specific aims of this trial are:
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study subjects must meet all of the following criteria:
Exclusion Criteria:
Subjects will be excluded if any of the following criteria exist:
United States, California | |||||
Stanford University | |||||
Stanford, California, United States, 94305-5401 |
National Institute of Child Health and Human Development (NICHD) |
Stanford University |
Duke University |
Principal Investigator: | Gregory Hammer, MD | Stanford University |
Principal Investigator: | Scott Schulman, MD | Duke University |
Responsible Party: | Stanford University ( Greg Hammer MD ) |
Study ID Numbers: | NICHD-2003-09-DR, NO1-HD-4-3386 |
First Received: | August 25, 2005 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00135668 |
Health Authority: | United States: Food and Drug Administration |
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