ACTRN12619000828123招募中2 期
Resuscitation in Paediatric Sepsis Using Early Inotropes– – A Randomized Controlled Trial to Assess Impact on Survival Free of Organ Dysfunction
niversity of Queensland0 个研究点目标入组 80 人开始时间: 2019年6月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 28 Days 至 17 Years(—)
- 性别
- All
入选标准
- •Children age =>28days and <18 years where the decision is made by the treating physician to launch the institutional paediatric sepsis bundle treating for sepsis or septic shock. To be eligible, the child must have received at least 20ml/kg of intravenous fluid bolus(es) in the past four hours with the clinician deciding to continue treating for signs of shock.
排除标准
- •- Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- •- Children who received =>40ml/kg of fluid during the 4 hours pre enrolment
- •- Children on Inotrope infusion
- •- Lack of access (intraosseus, central venous, peripheral) to administer fluids and/or inotropes after 60minutes of enrolment.
- •- Known cardiomyopathy or chronic cardiac failure
- •- Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment.
- •- Known chronic renal failure
- •- Known chronic hepatic failure
- •- Palliative care patient/patient with limitation of treatment (not for inotropes, CPR, ECLS, intubation and ventilation)
- •- Cardiopulmonary arrest in the past two hours requiring CPR >2 min, or death is deemed to be imminent or inevitable during this admission.
- •- Major bleeding with haemorrhagic shock
- •- Sepsis is not likely to be the cause of shock
- •- Enrolment in RESPOND study <6 months ago (except for RESPOND ED randomization prior to RESPOND PICU within the same sepsis episode)
研究者
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