DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017