Optic

ID

Name

NICHD-2003-09-DR

Description

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.

Trial arms

Trial start

2005-08-01

Estimated PCD

2008-03-01

Trial end

2009-02-01

Status

Completed

Phase

Early phase I

Treatment

Nitroprusside

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).

Arms:

0.3 mcg/kg/min

Other names:

Sodium Nitroprusside IV infusion 0.3 mcg/kg/ min

Nitroprusside

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.

Arms:

1 mcg/kg/min

Other names:

Sodium Nitroprusside IV infusion 1 mcg/kg/ min

Nitroprusside

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.

Arms:

2 mcg/kg/min

Other names:

Sodium Nitroprusside IV infusion 2 mcg/kg/ min

Nitroprusside

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

Arms:

3 mcg/kg/min

Other names:

Sodium Nitroprusside IV infusion 3 mcg/kg/ min

Size

211

Primary endpoint

Change in Mean Arterial Pressure (MAP) From the Baseline MAP

Approximately 30 minutes

Overall Summary of Tolerability/Adverse Events (AEs) for ITT Safety Population

30 days

Eligibility criteria

Inclusion Criteria: Study subjects must meet all of the following criteria: * Subject is less than 17 years of age * Neonates must be full-term gestation and have a body weight of at least 2.5 kg * Subject requires pharmacologically-induced hypotension for acute blood pressure management for surgery or other invasive procedure, e.g., cerebral artery embolization * Duration of the subject's controlled hypotension is expected to be ≥ 2 hours * Subject requires general anesthesia with endotracheal intubation * Subject requires placement of intra-arterial line during the surgical or medical procedure * The subject's parent or legal guardian gives permission (informed consent) and subject gives assent when appropriate. Exclusion Criteria: Subjects will be excluded if any of the following criteria exist: * Subject has a known allergy to SNP * Subject has a known mitochondrial cytopathy with a disorder of oxidative phosphorylation or of respiratory chain enzymes * Subject has a contraindication to vasodilator therapy for control of blood pressure during surgery or procedures * Subject has participated in other clinical trials for investigational drugs and/or devices within 30 days prior to enrollment * Subject has any serious medical condition which, in the opinion of the investigator, is likely to interfere with study procedures * Subject is moribund (death likely to occur within 48 hours) * Subject has a positive result for the urine or serum human chorionic gonadotropin (HCG) test administered at screening.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 211, 'type': 'ACTUAL'}}

Updated at

2024-01-02

Organization

The Emmes Company

Product

Nitroprusside

Indication

Low blood pressure

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