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临床试验/EUCTR2019-002020-33-PL
EUCTR2019-002020-33-PL进行中(未招募)1 期

Pentoxifylline dose optimization in neonatal sepsis. - Pentoxifylline in neonatal sepsis

Erasmus University Medical Center0 个研究点目标入组 40 人开始时间: 2021年3月29日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Neonates with gestational age <30 weeks
  • - Suspected of sepsis with blood drawn for blood culture and inflammatory biomarkers
  • - IL-6 > 500 pg/ml or if CRP > 50 mg/L
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 40
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - PTX therapy cannot be started within 24 hours of start of antibiotic treatment.
  • - Patients with major congenital defects (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies) will also be excluded.
  • - If subjects have IL-6 values exceeding 25000 pg/mL at time of onset they will also be excluded. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates.
  • - Patients who already participated in this trial during an earlier episode of late onset sepsis.
  • - Patients with pH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at start of sepsis episode.

研究者

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