Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- NO Outcomes - Study Terminated Without Data.
研究概览
简要总结
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.
- •Subject must have arterial or central venous lines to be enrolled.
- •Subject must have a documented weight of 2.5 Kilograms or greater.
- •Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.
排除标准
- •Medical urgency preventing timely administration of the consenting process.
- •Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.
- •Have given steroids intravenously (IV) or oral steroids within the last month.
- •Have a preexisting neuroendocrine disorder.
- •Have been treated with antipsychotic medication.
- •Have human immunodeficiency virus (HIV).
- •Have received etomidate for intubation.
- •Other technical considerations that would prevent acquisition of sufficient samples OR inability / unwillingness of the legal guardian to provide consent.
结局指标
主要结局
NO Outcomes - Study Terminated Without Data.
时间窗: Study terminated - no data.
次要结局
未报告次要终点
研究者
Kiran Hebbar
Assistant Professor - CT
Emory University