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临床试验/NCT02824705
NCT02824705已完成不适用

Effects of Cardiac ICU Practice Variation on Intestinal Epithelial Barrier Function and Microbiome Diversity

University of Arizona1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Change from baseline intestinal epithelial barrier biomarker profile

研究概览

简要总结

Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States. While advances in surgical treatment, cardiac bypass, and post-operative management have improved mortality for children born with heart defects, these children continue to have significant morbidity related to post-operative malnutrition, multiple organ dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity.

The purpose of this multi-center observational cohort study is to understand the extent to which practice variation for routine post-operative care might worsen intestinal barrier dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical correction of left sided cardiac obstructive defects. We will enroll 80 children with left sided obstructive congenital cardiac lesions across several US congenital cardiac centers to obtain clinical data and biological specimens. We will leverage existing differences in nutritional and antibiotic strategies at these centers to better understand how intestinal barrier function and the intestinal microbiome may contribute to post-operative multiple organ dysfunction syndrome.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Days 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pre-operative diagnosis of left sided obstructive congenital cardiac defect

排除标准

  • Corrected gestational age < 37 weeks at time of surgery
  • Short bowel syndrome
  • Intestinal graft vs. host disease
  • Inflammatory Bowel Disease (Ulcerative Colitis, or Crohn's disease)
  • Candidate for intestinal transplant
  • History of necrotizing enterocolitis (NEC)
  • Previous Randomization into this study

结局指标

主要结局

Change from baseline intestinal epithelial barrier biomarker profile

时间窗: 04/2016-01/31/2020

Microbiome diversity

时间窗: 04/2016-01/31/2020

次要结局

  • Multiple Organ Dysfunction Syndrome(04/2016-01/31/2020)

研究者

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

Katri Typpo

Principal Investigator

University of Arizona

研究点 (1)

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