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NCT Number: NCT00135668

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94305-5401, United States

About this study

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:

  • To define the onset and offset of blood pressure lowering effects of nitroprusside to obtain adequate instructions for dose titration in the pediatric population.
  • To construct a dose-response model that defines the relationship between nitroprusside infusion rate and changes in blood pressure in pediatric subjects.
  • To assess the safety of nitroprusside administration in pediatric subjects requiring controlled reduction of blood pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nitroprusside

Drug

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).

Other names: Sodium Nitroprusside IV infusion 0.3 mcg/kg/ min

Primary outcomes

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

    Time frame: Approximately 30 minutes

    From the Baseline MAP until the end of the blinded phase; scheduled for 30 min

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

    Time frame: 30 days

    Treatment-emergent AEs (TEAEs) were defined as an AE experienced by the patient that was either first observed after the initiation of study drug (blinded or open-label) or represented an exacerbation (usually in severity) of a pre existing condition observed prior to treatment. Subjects will be followed for 30 days after discontinuation of study drug. The occurrence of Serious Adverse Events (SAEs) will be monitored for 30 days.

Secondary outcomes

  1. Change From Baseline MAP Nitroprusside Infusion During the Blinded Infusion;

    Time frame: 25 minutes

    Change From Baseline in MAP (mmHg) After 20 and 25 Minutes Double-Blind Infusion (Overall) for ITT Efficacy Evaluable Population.

  2. Infusion Rate of Sodium Nitroprusside That Reduces MAP to a Predetermined Clinically Meaningful Target Value +/- 10%;

    Time frame: Up to the end of open label treatment (Approximately 120 minutes)

    Infusion rate of sodium nitroprusside at which a predetermined clinically meaningful target value (+/- 10%) of MAP was achieved during study drug administration

  3. Number of Participants Who Reach Target MAP;

    Time frame: To the end of open label treatment (approximately 120 minutes)

    Blinded Study Drug Administration Period: Started with study drug administration following stabilization of anesthesia. Patients were administered a blinded dose of SNP for up to 30 mins.

    This period ended at the start of open-label study drug infusion or at the completion of the blinded infusion if no open-label study drug was given. The follow-up period immediately followed for those patients not receiving open-label infusion.

    Blinded Treatment Phase II - gap between the end of blinded study drug infusion and the start of open-label study drug infusion

    Open-label treatment phase began with the start of open-label study drug infusion and was at least 90 mins in duration. SNP was initiated at a dose deemed appropriate by the investigator and was gradually adjusted to reach a target MAP based on clinical presentation and needs of the patient. Target MAP was not to be < 50 mmHg (40 mmHg for patients < 30 days of age). This period ended at the completion of open-label infusion.

Sponsors and collaborators

Lead sponsor

The Emmes Company, LLC

Industry

Collaborators

  • Duke University
  • Stanford University

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Aug 26, 2005
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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