We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00135668
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : May 27, 2009
Sponsor:
Collaborators:
Stanford University
Duke University
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: nitroprusside Phase 2

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1
Nitroprusside infusion 0.3 mcg/kg/min
 Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
Active Comparator: 2
nitroprusside infusion 1 mcg/kg/min
 Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
Active Comparator: 3
nitroprusside infusion 2 mcg/kg/min
 Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min
Active Comparator: 4
nitroprusside 3 mcg/kg/min
 Drug: nitroprusside
nitroprusside IV infusion 0.3-3 mcg/kg/ min


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The primary efficacy endpoint is the change in mean arterial pressure (MAP) from the baseline MAP after 30 minutes of blinded study drug administration with sodium nitroprusside

Secondary Outcome Measures :
  1. Secondary efficacy endpoints are:Offset MAP and time to return to offset MAP after the cessation of study medication;
  2. The change from baseline MAP during the initial 20 and 25 minutes of sodium nitroprusside infusion during the blinded infusion;
  3. The infusion rate of sodium nitroprusside that reduces MAP to a predetermined clinically meaningful target value +/- 10%;
  4. The proportion of patients who reach target MAP;
  5. The change in vital signs (i.e., systolic blood pressure [SBP], diastolic blood pressure [DBP], and heart rate [HR]) from baseline to 10, 15, 20, and 30 minutes post-infusion initiation.
  6. Analyses will be stratified by age

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135668


Locations
Layout table for location information
United States, California
Stanford University
Stanford, California, United States, 94305-5401
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Gregory Hammer, MD Stanford University
Principal Investigator: Scott Schulman, MD Duke University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Greg Hammer MD, Stanford University
ClinicalTrials.gov Identifier: NCT00135668    
Other Study ID Numbers: NICHD-2003-09-DR
NO1-HD-4-3386
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
children
sodium nitroprusside
controlled hypotension
dose-response
 pharmacokinetics
pharmacodynamics
safety
efficacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypotension
Vascular Diseases
Cardiovascular Diseases
Nitroprusside
 Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action