Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)
Completed · Phase 2 · Has a placebo group
Conditions studied: Hypertension
In brief
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, and if when the nitroprusside is stopped the blood pressure goes up at a faster rate and is higher than it was at the start of the treatment. This study will answer these questions.
Key facts
- Study ID
- NCT00621816
- Run by
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- People needed
- 45
- Starts
- 2009-01-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-12-06
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)]
You may not qualify if…
- 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.
Where it is running
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- Stanford University School of Medicine — Stanford, California, United States
- Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
- University of Michigan - Mott Children's Hospital — Ann Arbor, Michigan, United States
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- West Virginia University — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
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