Prospective Incidence of Persistent Inflammatory, Immunosuppressed, Catabolic Syndrome in the Critically Ill Pediatric Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Occurrence of PICS in the pediatric critical care population
研究概览
简要总结
Advances in modern medicine and critical care interventions have greatly impacted survival of critically ill patients, but these interventions are not without consequences. Although patients may now survive the initial critical illness, these patients may not recover to their pre-illness baseline state of health. Recent data in both the critically ill adult and neonatal patients who survive sepsis or surgical events have been shown to progress to persistent inflammatory, immunosuppressed, catabolic syndrome (PICS). This was first identified in adult trauma patients, and more recently was defined in critically ill neonates. To date, there are no published reports of PICS in the critically ill pediatric population. Our long-term goal is to understand PICS in the pediatric population and how early medical and nutritional interventions may impact overall morbidity and survival. To achieve this goal first PICS must first be characterized in the pediatric population. The hypothesis is that PICS occurs in pediatric patients and is associated with increased time to return to a baseline functional life post-injury or illness. The hypothesis will be tested by pursuing the following specific aims. Specific Aim 1: To determine the incidence of PICS in the pediatric population and associate the diagnosis of PICS to survival and time to return to baseline functional life and Specific Aim 2: To determine if early increased inflammatory and immunosuppressive markers are associated with the development of PICS and increased morbidity and mortality. These aims will be accomplished by conducting a prospective single-center observational pilot study to enroll pediatric patients with an anticipated pediatric intensive care unit (PICU) stay greater than 14 days. Through these two aims, the investigators anticipate that this research will provide an explanation into the interplay of inflammation, immunosuppression, and catabolism in critically ill children, which is imperative to the development of early therapeutic and nutritional interventions that can reduce morbidity and mortality associated with critical illness.
详细描述
The long-term goal of this study is to understand PICS in the pediatric population and how early medical and nutritional interventions may impact overall morbidity and survival, but first PICS must be characterized in the pediatric population. The hypothesize is that PICS occurs in pediatric critically ill patients and is associated with increased time to return to a baseline functional life post-injury or illness.
Enrollment/Randomization This is a prospective observational study with no randomization. The patients will be approached between PICU stay days 9-12 for consent. Labs will be drawn between PICU stay days 12-16 with a preference for PICU day 14, however, labs will be drawn in accordance with the standard of care labs to avoid additional draws.
Study Procedures
Specific Aim 1: To determine the incidence of PICS in the pediatric population and associate the diagnosis of PICS to survival and time to return to baseline functional life.
In order to determine the incidence of PICS in PICU patients, a prospective single-center study will be conducted of all critically ill pediatric patients admitted to PICU at Riley Hospital for Children at Indiana University Health, Indianapolis, IN. Patients will be included if they have an anticipated stay of >14 days in the PICU. Patients will be excluded from this study if they have are maintained on chronic mechanical ventilation, have a known chronic inflammatory disease process, or are diagnosed with failure to thrive or malnutrition upon admission to the PICU.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are < or = to 18 years of age and have an anticipated length of PICU stay of > or = to 14 days from June 1, 2018 through January 31, 2019
排除标准
- •Chronic mechanical ventilation, Known chronic inflammatory disease process, or Diagnosed with failure to thrive or malnutrition upon admission to the PICU
结局指标
主要结局
Occurrence of PICS in the pediatric critical care population
时间窗: July 1, 2018 to June 30, 2019
Diagnosis of PICS will be determined when a patient has been admitted to the PICU for \>14 days and has signs of both inflammation (CRP \>15mg/L) and immunosuppression (total lymphocyte count \< 0.80×109/L), as well as catabolism (Serum albumin \< 3.0g/dL, Prealbumin \<10mg/dL, Retinol binding protein \<10μg/dL, and weight loss \>10% or body mass index \<18 during hospitalization).
次要结局
- Mortality(July 1, 2018 to June 30 2019)
研究者
Courtney Rowan
Assistant Professor Pediatrics
Indiana University
