At a glance
ClinicalIndex Comparison Record- ✓Age less than 17 years; neonates must be full-term with body weight ≥2.5 kg
- ✓Requires pharmacologically-induced hypotension for acute blood pressure management during surgery or invasive procedure (e.g., cerebral artery embolization)
- ✓Expected duration of controlled hypotension ≥2 hours
- ✓Requires general anesthesia with endotracheal intubation
- ✕Known allergy to sodium nitroprusside (SNP)
- ✕Known mitochondrial cytopathy with disorder of oxidative phosphorylation or respiratory chain enzymes
- ✕Contraindication to vasodilator therapy for blood pressure control during surgery or procedures
- ✕Participation in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Multicenter, Randomized, Double-blind, Parallel Group, Dose-ranging, Effect-controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside in Pediatric Subjects
In Brief
A Phase 2 clinical trial evaluating Nitroprusside for Hypotension. Completed, enrolled 211 participants across 1 site.
Detailed Summary
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children. The purpose of this study is to determine the efficacy and safety of sodium nitroprusside in children who will be having surgery, and who require blood pressure lowering in order to decrease the amount of blood loss during their surgery.
Study Details
Timeline
Interventions
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS (Interactive Voice Response System).
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS.
Study drug was infused via a dedicated peripheral intravenous catheter or via a dedicated lumen of a multi-orifice central venous catheter. Infusion pumps capable of reliable delivery at low infusion rates (to 0.1 mL/hr) were used.Study drug was dispensed to the sites in 2 mL vials containing 25 mg/mL of sodium nitroprusside. The pharmacist prepared and dispensed the study drug, and supplied blinded study drug for each subject according to a randomization assignment generated by the IVRS