Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135668
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2005-08-25
Brief Title:
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Sponsor:
The Emmes Company LLC
Organization:
The Emmes Company LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01HD43386-7-0-1 | NIH | None | httpsreporternihgovquickSearchN01HD43386-7-0-1 |