NCT00621816已完成2 期
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)7 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 7
- 主要终点
- The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is less than 17 years of age.
- •An in-dwelling arterial line is clinically indicated.
- •Subject's parent or legal guardian is willing and able to give informed parental permission signing and dating an IRB-approved informed parental permission containing all of the elements of informed consent, and subject provides assent, signing an IRB-approved and -required informed assent, if applicable.
- •Subject is anticipated to require a minimum of 20 mm Hg (15 mm Hg for subjects < 2 years old) reduction in MAP for at least 12 hours using SNP [i.e., MAPB1 - MAPB2 ≥ 20 mm Hg (15 mm Hg for subjects < 2 years old)]
- •Exclusion criteria:
- •Subject weighs < 3.0 kg.
- •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 in the intensive care unit.
- •Subject has raised intracranial pressure.
- •Subject is anticipated to need anti-hypertensive drugs other than Sodium Nitroprusside either IV (e.g. dexmedetomidine, esmolol, etc.) or epidural (e.g.local anesthetics, clonidine, etc.) within three terminal half-lives (3X T½ β) of the blinded study drug period. However, patients receiving stable doses of an anti-hypertensive drug(s) prior to the initiation of study drug may be enrolled.
- •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 HCG test administered at screening.
- •Subject has participated in other clinical trials for investigational drugs within 30 days prior to enrollment
- •Subject has received or will have received Sodium Thiosulfate within 6 hours prior to the start of the open-label period.
- •Subject is either on, or anticipated to be on, ECMO.
排除标准
- 未提供
研究组 & 干预措施
1
Active Comparator
Blinded nitroprusside infusion
干预措施: nitroprusside (Drug)
2
Placebo Comparator
Blinded placebo infusion
干预措施: placebo infusion (Drug)
结局指标
主要结局
The primary endpoint is the change in MAP during the Blinded Study Drug Administration Phase in the absence of other stimuli.
时间窗: 8 months
次要结局
- 1. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience offset during the 30-minute blinded study drug period.(8 months)
- 2. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience rebound hypertension during blinded study drug period(8 months)
- 3. To compare the proportion of patients randomized to receive either sodium nitroprusside or placebo who experience a serious adverse event during the 30-minute blinded study drug period(8 months)
- 4. To compare the distribution of patients randomized to receive either sodium nitroprusside or placebo who experience a treatment-emergent and related adverse event, by maximum severity grade, during the 30-minute blinded study drug period.(8 months)
- 5. To compare the changes in vital signs (systolic blood pressure, diastolic blood pressure, MAP, and heart rate) between patients randomized to receive either sodium nitroprusside or placebo(8 months)
- 6. To compare the changes in individual laboratory parameters between patients randomized to receive either sodium nitroprusside or placebo.(8 months)
研究者
研究点 (7)
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