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临床试验/NCT02644824
NCT02644824已完成不适用

Biventricular Pacing in Children With Wide QRS After Surgery for Congenital Heart Disease

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Change in Cardiac Index (CI)

研究概览

简要总结

Surgery with cardiopulmonary bypass (CPB) for congenital heart disease (CHD) causes low cardiac index (CI). With the increasing success of surgery for CHD, mortality has decreased and emphasis has shifted to post-operative morbidity and recovery. Children with CHD undergoing surgery with CPB can experience well-characterized post-operative cardiac dysfunction. When severe, patients can develop clinically important low cardiac output syndrome (LCOS) and hemodynamic instability. Management of LCOS and hemodynamic compromise is primarily accomplished via intravenous durgs like milrinone, dopamine or dobutamine, which affect the strength of the heart's muscular contractions. These are used to maintain adequate blood pressure (BP) and CI. However, inotropic agents are potentially detrimental to myocardial function and may increase risk for post-operative arrhythmia and impair post-operative recovery by increasing oxygen demand and myocardial oxygen consumption (VO2). In combination with the increased VO2 associated with CPB-induced systemic inflammatory response patients can develop a critical mismatch between oxygen supply and demand, essentially the definition of LCOS. Therefore, therapies that improve CI and hemodynamic stability without increased VO2 are beneficial. This study will test whether BiVp, a specialized yet simple pacing technique, can improve post-operative CI and recovery in infants with electro-mechanical dyssynchrony (EMD) after CHD surgery. This study hypothesizes that Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.

详细描述

Research Design: Pilot-study for a large prospective, randomized, single-blinded, clinical trial.

This study is a parallel-arm, randomized, single-blinded clinical trial based on a hemodynamic outcome that will inform a subsequent larger randomized trial based on clinical outcomes.

Main research question: Does continuous BiVp for up to 48 hours in infants with EMD after CHD surgery increase CI as measured every 1-3 hours by the Fick method using an AMIS2000 mass spectrometer for VO2 measurement? Primary Hypothesis: Continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery compared to standard care alone.

Primary objective: The primary objective of this pilot study is to provide physiologic proof of principle data by testing the hypothesis that continuous BiVp increases the mean change in CI from baseline to 48 hours in infants with EMD following CHD surgery. Although this is suggested by our preliminary data, the number of infants with wide QRS was small and statistically underpowered. The current study will expand the target population and provide preliminary data for sample size calculation and outcome measures for a subsequent, larger, clinical trial based on clinical outcomes such as duration of mechanical ventilation, length of ICU stay and vasoactive-inotropic score.

Secondary Hypotheses:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Infants 0-1 year with Congenital Heart Disease
  • Patients with functionally univentricular heart disease
  • Informed consent

排除标准

  • Infants <2.5 kg at time of surgery
  • Infants with biventricular heart disease
  • Informed consent is not given

研究组 & 干预措施

Biventricular Pacing (BiVp)

Experimental

Consented infants with wide QRS randomized to receive standard of care and BiVp.

干预措施: Biventricular Pacing (BiVp) (Device)

Control (wide QRS)

No Intervention

Consented infants with wide QRS randomized to receive standard of care alone.

Control (narrow QRS)

No Intervention

This is an observation control group. Consented infants with narrow QRS will enter control group 2 without randomization.

结局指标

主要结局

Change in Cardiac Index (CI)

时间窗: Pre-operative, baseline, and every 24 hours during care up to 48 hours

The overall mean change in CI from baseline (average of 1st 2 CI measurements) to study end (average of last 2 measurements) in BiVp vs. controls.

次要结局

  • Mechanical Dyssynchrony(Pre-operative, baseline, and at study endat 48 hours)
  • Duration of Mechanical Ventilation(From baseline to extubation at 48 hours)
  • End Organ Perfusion(Pre-operative, baseline, and every 24 hours during care and up to 48 hours)
  • QRS Duration(Pre-operative, baseline, and at study end of 48 hours)
  • Vasoactive-inotropic Score(Change from baseline of vasoactive-inotropic score to end of care and up to 48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Friedberg

Staff Cardiologist

The Hospital for Sick Children

研究点 (2)

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