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临床试验/NCT03320967
NCT03320967已完成不适用

COpeptin in Critically Ill Paediatric and Neonatal Intensive Care Patients and Its Association With Arterial Hypotension. A Single-centre Prospective Observational Study.

Vincenzo Cannizzaro1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2017年12月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
170
试验地点
1
主要终点
Blood copeptin in arterial normo- and hypotension

研究概览

简要总结

Blood copeptin will be measured during the routine treatment of neonates, children and adolescents on the Intensive Care Unit of the University Children's Hospital Zurich at different time points (admission, 12, 24, 48, 96, 168 hours after admission). These values will be primarily analysed for their variability and their association with arterial hypotension. Blood samples will be drawn together with otherwise medically indicated blood withdrawals to avoid extra harm. Further, copeptin values will be compared to clinical and vital parameters, all of them open-label available during clinical routine. Copeptin's predictive value for patients' outcome will be analysed as secondary outcome.

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
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: first day of life until 18th birthday.
  • Ability of the care taker or the adolescent (if≥14 years of age) to understand verbal and written instructions and informed consent in German.

排除标准

  • Care taker or adolescent (if ≥14 years of age) unwilling to give written informed consent.
  • Care taker or adolescent (if ≥14 years of age) not understanding German and without a family member able to translate.
  • Adolescent (if ≥14 years of age) unwilling to give written informed consent following sedation < 24 hours.
  • Care takers of long-term sedated (>24 hours) adolescents (if ≥14 years of age) unwilling to give written informed consent or not present within 24 hours.

结局指标

主要结局

Blood copeptin in arterial normo- and hypotension

时间窗: Up to 168 hours.

Average change of blood copeptin in patients with both arterial normo- and hypotension and different pathologies.

次要结局

  • Length of respiratory support(Up to 168 hours.)
  • Length and dose of catecholamine therapy(Up to 168 hours.)
  • Length of stay on the intensive care unit(Up to 168 hours.)
  • Rate of death(Up to 168 hours.)

研究者

发起方
Vincenzo Cannizzaro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vincenzo Cannizzaro

Vice-head Department of Pediatric Intensive Care and Neonatology

University Children's Hospital, Zurich

研究点 (1)

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