Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Survival free of organ support at 28 days
研究概览
简要总结
Septic shock in children still carries substantial mortality and morbidity. While resuscitation with 40-60 mL/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. The investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. Here, the investigators describe the protocol of the Adrenaline in Early Sepsis Resuscitation in Children- A Randomised Controlled Pilot Study in the Emergency Department (ANDES CHILD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •28 days and <18 years
- •Treated for sepsis
- •Received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock
- •Parental/caregiver consent prior to or after enrolment
排除标准
- •Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- •Received ≥ 40 mL/kg of fluid boluses during the 4 h pre-enrolment
- •Inotrope infusion commenced pre-enrolment
- •Lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment
- •Cardiomyopathy or chronic cardiac failure
- •Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment
- •Known chronic renal failure (defined as requiring renal replacement therapy)
- •Known chronic hepatic failure
- •Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation)
- •Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, 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
- •Previous enrollment in ANDES-CHILD
研究组 & 干预措施
Control group
Sepsis will be treated with a standardized therapy protocol, where participants will receive fluids for resuscitation. Specifically, they will receive 40-60 ml/kg of fluids before the initiation of inotropes
干预措施: Fluid (Other)
Intervention group
Sepsis will be treated with early inotropes, where participants will receive adrenaline after the first bolus of 20 ml/kg
干预措施: Adrenalin (Drug)
结局指标
主要结局
Survival free of organ support at 28 days
时间窗: From time of randomization until 28 days, if death occurs, time is set to 0 days
Organ support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy
次要结局
- Hospital length of stay(28 days)
- Modified Pediatric Overall Performance Category at 28 days(28 days)
- Amount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment(24 hours)
- Recuitment rates(12 months)
- Time to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days(28 days)
- Time to initiation of inotropes between the control and the early inotrope arm(24 hours)
- Amount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm(24 hours)
- 28-day mortality(From time of randomization until 28 days)
- Survival free of PICU censored at 28 days(28 days)
- Functional Status Score at 28 days(28 days)
- Proportion of eligible randomised(12 months)
- Proportion of eligible consented using perspective consent and consent to continue(12 months)
- Protocol violations(12 months)
- Survival free of invasive ventilation support at 7 days(7 days)
- Time to reversal of tachycardia during the first 24 h(24 hours)
- Survival free of inotrope support at 7 days(7 days)
- PICU length of stay(28 days)
- Proportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment(24 hours)
研究者
NATALIA LOPERA MUNERA
Pediatrician, principal investigator
Hospital General Pediátrico Niños de Acosta Ñu