Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)
Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: nitroprusside (Drug); placebo infusion (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s): Scott Schulman, MD, Principal Investigator, Affiliation: Duke University Greg Hammer, MD, Principal Investigator, Affiliation: Stanford University
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, 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.
Clinical Details
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Pharmacodynamics of Sodium Nitroprusside During Prolonged Infusion in Pediatric Subjects
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
Secondary outcome: 1. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience offset during the 30-minute blinded study drug period.2. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience rebound hypertension during blinded study drug period 3. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience a serious adverse event during the 30-minute blinded study drug period 4. To compare the distribution of patients randomized to receive either sodium nitroprusside or placebo who experience a treatment-emergent and related adverse event, by maximum severity grade, during the 30-minute blinded study drug period. 5. To compare the changes in vital signs (systolic blood pressure, diastolic blood pressure, MAP, and heart rate) between patients randomized to receive either sodium nitroprusside or placebo 6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo.
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 rebound hypertension associated with prolonged infusion in pediatric subjects.
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase
in the absence of other stimuli.
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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 [i. e., MAPB1 - MAPB2 ≥ 20
mm Hg (15 mm Hg for subjects < 2 years old)]
Exclusion criteria:
1. Subject weighs < 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 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.
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 within 30
days prior to enrollment
11. Subject has received or will have received Sodium Thiosulfate within 6 hours prior to
the start of the open-label period.
12. Subject is either on, or anticipated to be on, ECMO.
Locations and Contacts
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States
Stanford University School of Medicine, Stanford, California 94305, United States
Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky 40202, United States
University of Michigan - Mott Children's Hospital, Ann Arbor, Michigan 48109-0243, United States
University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27500, United States
Duke University Medical Center, Durham, North Carolina 27705, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
West Virginia University, Morgantown, West Virginia 26506, United States
Additional Information
Starting date: January 2009
Last updated: December 2, 2011
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