Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
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
Sponsor: Duke University
Listed as NCT00135668, this PHASE2 trial focuses on Hypotension and remains completed. Sponsored by Duke University, it has been updated 8 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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:
1. To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population.
2. To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects.
3. To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.
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:
1. To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population. 2. To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects. 3. To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Feb 2024 — Jul 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Feb 2024 [monthly]
Completed PHASE2
▶ Show 3 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Aug 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Duke University
- Stanford University
- The Emmes Company, LLC
For direct contact, visit the study record on ClinicalTrials.gov .