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Dose-Response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room

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: Hypotension

Intervention: nitroprusside (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):
Gregory Hammer, MD, Principal Investigator, Affiliation: Stanford University
Scott Schulman, MD, Principal Investigator, Affiliation: Duke University

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary efficacy endpoint is the change in mean arterial pressure (MAP) from the baseline MAP after 30 minutes of blinded study drug administration with sodium nitroprusside

Secondary outcome:

Secondary efficacy endpoints are:Offset MAP and time to return to offset MAP after the cessation of study medication;

The change from baseline MAP during the initial 20 and 25 minutes of sodium nitroprusside infusion during the blinded infusion;

The infusion rate of sodium nitroprusside that reduces MAP to a predetermined clinically meaningful target value +/- 10%;

The proportion of patients who reach target MAP;

The change in vital signs (i.e., systolic blood pressure [SBP], diastolic blood pressure [DBP], and heart rate [HR]) from baseline to 10, 15, 20, and 30 minutes post-infusion initiation.

Analyses will be stratified by age

Detailed description: The trial is a multicenter randomized, double-blind, parallel group, dose-ranging, effect-controlled study examining the effects of sodium nitroprusside in pediatric subjects requiring relative hypotension during a surgical or medical procedure. The goal is to establish the starting and maximum infusion rates that afford optimum blood pressure control in children and a safe dosing regimen in children. The objective is to describe the relationship between the infusion rate of nitroprusside and changes in blood pressure. The specific aims of this trial are: 1. To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population. 2. To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects. 3. To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.

Eligibility

Minimum age: N/A. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

Stanford University, Stanford, California 94305-5401, United States
Additional Information

Starting date: August 2005
Last updated: May 26, 2009

Page last updated: August 23, 2015

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