Sodium Nitroprusside for Blood Pressure Reduction in the ICU (SNP2)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypertension

Interventions

nitroprussideDRUG

nitroprusside continuous infusion, dose to be titrated to clinical effect

placebo infusionDRUG

blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion

Eligibility

Sex: ALLMin age: 1 DayMax age: 17 Years

Medical Language ↔ Plain English

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 (8)

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

Outcomes

Primary Outcomes

The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.

Time frame: 8 months

Secondary Outcomes

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.

Time frame: 8 months

2. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience rebound hypertension during blinded study drug period

Time frame: 8 months

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

Time frame: 8 months

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.

Time frame: 8 months

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

Time frame: 8 months

6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo.

Time frame: 8 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.