Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Vasopressin and copeptin levels
研究概览
简要总结
Patients with severe infection can develop very low blood pressure. There are many mechanisms leading to this, and one of them appears to involve a hormone called vasopressin. In children as compared to adults, the mechanism and response to low blood pressure are different for reasons that are not clear. One possibility is the difference in the production and/or response to vasopressin. Vasopressin has become part of the treatment of children with low blood pressure in the setting of severe infection, when other treatment has failed, but its use is on the basis of animal and adult studies. The exact timing and dose is uncertain.
In this research study, the patients will receive standard treatment for sepsis and septic shock, and the investigators will measure the blood levels of vasopressin and a related compound called copeptin (both are required to understand the mechanism of control involved). Blood will need to be taken from patients without any sepsis so as to be able to compare the values in health and in sickness. The patient groups the investigators have chosen for this are those children who will have blood taken anyway as part of their routine care. The aim of this study is to develop an understanding of the body's hormonal response (with respect to vasopressin) to severe infection in children. The long-term aim is to improve the care of critically ill children with severe infection by using the most appropriate dose of vasopressin at the most appropriate time.
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
- 1 Day 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Control Group:
- •Neonates admitted for neonatal jaundice requiring phototherapy
- •Previously well patients admitted for elective gastrointestinal endoscopy, patients admitted for non-specific abdominal pain and
- •Pre-operative patients for circumcision, inguinal hernias and chronic orthopaedic conditions
- •Study Group:
- •The investigators will also enroll children with sepsis and septic shock
- •Sepsis will be defined as proposed by the International pediatric sepsis consensus conference.
- •Children will be recruited into the septic shock group if they have sepsis and features of cardiovascular organ dysfunction as defined by the same consensus conference.
排除标准
- •Neonates weighing less than 2.5 kg
- •Neonates less than 36 weeks gestation
- •Children more than 16 years of age
- •Patients with a history of congenital heart disease
- •Patients with chronic renal impairment
- •Patients with chronic liver impairment
- •Patients on active chemotherapy
- •Patients on chronic mineralocorticoids or glucocorticoids therapy
- •Patients on long-term diuretic therapy
- •Patients with central nervous system tumours
- •Patients with developmental delay
结局指标
主要结局
Vasopressin and copeptin levels
时间窗: First 5 days of admission
次要结局
未报告次要终点
研究者
Jan Hau Lee
Dr Lee Jan Hau
KK Women's and Children's Hospital
