NCT00621816

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	nitroprusside	nitroprusside continuous infusion, dose to be titrated to clinical effect
DRUG	placebo infusion	blinded placebo infusion, to be infused at same rate as open-label nitroprusside infusion

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-02-22
• Last updated: 2011-12-06

Locations

8 sites across 1 country: United States