Saraswati Kache
Long term (12-24 hrs) infusion of nitroprusside (SNP) in pediatric patients to study the tolerability, safety, and pharmacodynamics of SNP.
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Subjects who require vasodilator therapy for relatively long time periods will receive open-label infusion of sodium nitroprusside for at least 12 hours but not greater than 24 hours. Patients will be randomized to receive either placebo or sodium nitroprusside for 30 minutes following at least 12- hours but not more than 24 hours of open-label infusion of sodium nitroprusside. The safety of the drug will be assessed by multiple subject assessments of vital signs, physical exams, clinical tests and laboratory evaluations. Adverse events will be monitored and tracked. All SAEs will be closely monitored throughout the course of the study.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: sodium nitroprusside
Phase:
Phase 2Eligibility
Ages Eligible for Study:
Any Age to 16 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Subject is less than 17 years of age.
2. An in-dwelling arterial line is clinically indicated.
3. Subject?s parent or legal guardian is willing and able to give informed parental permission signing and dating an IRB-approved informed parental permission containing all of the elements of informed consent, and subject provides assent, signing an IRB-approved and ?required informed assent, if applicable.
4. Subject is anticipated to require a minimum of 20 mm Hg (15 mm Hg for subjects < 2 years old) reduction in MAP for at least 12 hours using SNP.
Key Exclusion Criteria:
1. Subject weighs less than 3.0 kg.
2. Subject has a known allergy to SNP.
3. Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes.
4. Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or in the intensive care unit.
5. Subject has raised intracranial pressure.
6. Subject is anticipated to need anti-hypertensive drugs other than study drug either IV (e.g. dexmedetomidine, esmolol, etc.) or epidural (e.g. local anesthetics, clonidine, etc.) during the period of study drug administration. However, patients receiving stable doses of an anti-hypertensive drug(s) prior to the initiation of study drug may be enrolled, provided they will not have received IV vasodilator therapy for greater than 8 hours prior to receiving study drug.
7. Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures.
8. Subject is moribund (death likely to occur within 48 hours).
9. Subject has a positive result for the urine or serum HCG test administered at screening.
10. Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
Additional Study Details
Official Title:
A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE PHARMACODYNAMICS OF SODIUM NITROPRUSSIDE DURING PROLONGED INFUSION IN PEDIATRIC SUBJECTSAnticipated start date:
1/26/2009Lead Sponsor:
Duke University is listed on CT.gov as the main PICollaborator(s):
- Duke
- West Virginia University
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
PharmacodynamicsPrimary Outcomes:
- To determine the persistence of the effect of sodium nitroprusside on blood pressure during stable infusion regimens lasting at least 12 hours
- To assess the potential for rebound hypertension during the 30-minute Blinded Phase following administration of sodium nitroprusside for 12 hours or more.
Secondary Outcomes:
- 1. To compare the patients who received placebo vs SNP during blinded phase for the following: serious adverse events; adverse events; and changes in vital signs from baseline to those in blinded.
Total Number to be Enrolled:
60Total Number to be Enrolled at Stanford:
4More Information
Secondary ID(s):
- IRB # 15043
- SPO 30011
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
3/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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