Status:
COMPLETED
Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Hypertension
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
Brief Summary
Nitroprusside is used commonly in the Intensive Care Unit for long periods of time in order to reduce blood pressure. It is not known if the body compensates over time to the blood pressure lowering, ...
Detailed Description
This is a phase 2, multicenter, randomized, double-blind placebo-controlled, parallel group study to determine the persistence of the effect of SNP on blood pressure and to assess the potential for re...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subject is less than 17 years of age.
- An in-dwelling arterial line is clinically indicated.
- 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.
- 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 \[i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects \< 2 years old)\]
- Exclusion criteria:
- Subject weighs \< 3.0 kg.
- 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 in the intensive care unit.
- Subject has raised intracranial pressure.
- Subject is anticipated to need anti-hypertensive drugs other than Sodium Nitroprusside either IV (e.g. dexmedetomidine, esmolol, etc.) or epidural (e.g.local anesthetics, clonidine, etc.) within three terminal half-lives (3X T½ β) of the blinded study drug period. However, patients receiving stable doses of an anti-hypertensive drug(s) prior to the initiation of study drug may be enrolled.
- 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 HCG test administered at screening.
- Subject has participated in other clinical trials for investigational drugs within 30 days prior to enrollment
- Subject has received or will have received Sodium Thiosulfate within 6 hours prior to the start of the open-label period.
- Subject is either on, or anticipated to be on, ECMO.
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00621816
Start Date
January 1 2009
End Date
January 1 2011
Last Update
December 6 2011
Active Locations (8)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
4
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109-0243