Role of Inferior Vena Cava Collapsibility Index or Central Venous Pressure as a Predictor of Fluid Responsiveness in Pediatric Sepsis Due to Perforated Viscus: Prospective Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the length of hospital stays
研究概览
简要总结
Pediatric population who suffered from sepsis due to perforated viscus will receive fluid resuscitation guided by either central venous pressure or guided by IVC collapsibility index.
The method of guidance of fluid therapy will be applied pre, intra, and postoperatively.
Primary outcome will be the length of hospital stays, while the secondary outcomes will be the incidence of complications and the length of PICU stays
详细描述
This prospective randomized double-blind study will be carried out on 44 pediatric patients who will be presented to Tanta university hospitals with sepsis owing to perforated viscus, an informed written consent will be obtained from all the parents of the participants, all patients data will be confidential and will be used for the current study only.
Ethical Considerations
Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus will be included
Patients will be randomly classified using a computer-generated software of randomization into 2 groups:
Group I (CVP group): patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The investigated patients are children aged 1-5 years. Measurements will be obtained by an assistant nurse not participating in the study and blinded to its groups.
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged 1 to 5 years presented with septic shock due to perforated viscus according to definition of the American College of Critical Care Medicine and International Pediatric Sepsis Consensus.
排除标准
- •Refusal of the parents to participate in the study
- •Congenital heart diseases
- •Severe arrythmias
- •Patients developed moderate to severe ARDS
- •Massive ascites
- •Previous abdominal surgery
- •Previous cardiothoracic surgery
研究组 & 干预措施
Group I (CVP)
patients in this group will receive fluid resuscitation and therapy guided by central venous pressure.
干预措施: Central venous catheter (Procedure)
Group II (IVC)
patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index.
干预措施: Central venous catheter (Procedure)
Group II (IVC)
patients in this group will receive fluid resuscitation and therapy guided by IVC collapsibility index.
干预措施: IVC collapsibility index (Diagnostic Test)
结局指标
主要结局
the length of hospital stays
时间窗: within first 28 days
The number of days from admission of the child till discharge
次要结局
- The length of PICU stays(within first 28 days)
- The incidence of complications(within first 28 days)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University