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临床试验/NCT00698048
NCT00698048已完成不适用

Serial Vasopressin and Copeptin Levels in Children With Sepsis and Septic Shock

Jan Hau Lee1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2008年8月最近更新:
适应症

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

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

发起方
Jan Hau Lee
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Jan Hau Lee

Dr Lee Jan Hau

KK Women's and Children's Hospital

研究点 (1)

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