Status:
COMPLETED
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Lead Sponsor:
The Emmes Company, LLC
Collaborating Sponsors:
Stanford University
Duke University
Conditions:
Hypotension
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
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...
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 hypote...
Eligibility Criteria
Inclusion
- Study subjects must meet all of the following criteria:
- Subject is less than 17 years of age
- Neonates must be full-term gestation and have a body weight of at least 2.5 kg
- Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization
- Duration of the subject's controlled hypotension is expected to be ≥ 2 hours
- Subject requires general anesthesia with endotracheal intubation
- Subject requires placement of intra-arterial line during the surgical or medical procedure
- The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate.
Exclusion
- Subjects will be excluded if any of the following criteria exist:
- Subject has a known allergy to SNP
- Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes
- Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures
- Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
- Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures
- Subject is moribund (death likely to occur within 48 hours)
- Subject has a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00135668
Start Date
August 1 2005
End Date
February 1 2009
Last Update
January 2 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305-5401