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临床试验/CTRI/2018/10/016169
CTRI/2018/10/016169已完成4 期

Superior venacaval oxygen saturation monitoring (Intermittent / Continuous) based Goal Directed Therapy vs Standard Care in Children with Septic Shock: An Open Label Randomized Control Trial

PGIMER0 个研究点目标入组 92 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
PGIMER
入组人数
92

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • i. All children >= 6 month to <12 years
  • ii. Presenting to Pediatric ER with clinical septic shock
  • iii. Developing it within 24 hours of admission to Pediatric ER
  • Septic shock will be defined by presence of clinically suspected sepsis with cardiovascular organ dysfunction i.e., children with persistent hypotension (MAP <5th centile for age and gender) despite 40 ml/kg of resuscitation fluid and requiring vasoactive drug infusion during first 1 hour.

排除标准

  • i. Contraindications for central neck venous line insertion (IJV or Subclavian vein) like bleeding tendencies, or not accessible for line insertion due to short neck or local disease.
  • ii. Children already on inotrope with inotrope score of >10 at arrival to our hospital.
  • iii. Children with known or suspected congenital heart disease
  • iv. Immunocompromised patients, e.g., primary immunodeficiency disorders, HIV (exposed or positive), patients with malignancies or other diseases on immunosuppressive medications including steroids.
  • v. Children with chronic illness like tuberculosis, chronic liver disease, chronic kidney disease, chronic respiratory disease etc.
  • vi. Known Inborn errors of metabolism
  • vii. Children with shock primarily due to diarrhea and severe dehydration.
  • viii.Children with suspected healthcare associated infection

研究者

发起方
PGIMER

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