Therapeutic Plasma Exchange in Children With Severe Sepsis and Septic Shock: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The aim of the study will be to to evaluate whether therapeutic plasma exchange (TPE) reduces mortality in critically ill children with severe sepsis or septic shock compared to the standard care of sepsis alone.
The study population will be divided into two groups, the first group will receive standard sepsis management plus therapeutic plasma exchange and the second one will receive the standard sepsis management alone . Then we will assess the effect of TPE on : Severity of organ dysfunction (pSOFA score) , duration of vasopressor support , length of PICU stay, time to hemodynamic stabilization , and on inflammatory and coagulation biomarkers
详细描述
This will be a Prospective, randomized, controlled, open- label, parallel-group, center clinical trial, which will be conducted on critically ill children with severe sepsis and septic shock, admitted into the Pediatric Intensive Care Unit (PICU) of Menoufia University Hospital from August 2026 to February 2027.
Eligible patients will be randomized using a computer-generated random sequence into:
- - Intervention Group (plasma exchange Arm): Standard sepsis management plus therapeutic plasma exchange.
- - Control Group (Standard care Arm): Standard sepsis management alone. Interventions
Standard Care (Both Groups):
- - Early antimicrobial therapy
- - Fluid resuscitation.
- - Vasopressor and inotropic support
- - Mechanical ventilation as indicated
- - Organ support according to PICU protocols Therapeutic Plasma Exchange (TPE) Protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From one month to 18 years.
- •With an established diagnosis of severe sepsis or septic shock according to international pediatric sepsis definitions.
排除标准
- •Known congenital bleeding disorders and severe uncontrolled hemorrhage.
- •End-stage chronic illness with expected survival < 3 months.
- •Previous plasma exchange during the same admission.
- •Contraindications to central venous catheterization.
结局指标
主要结局
Primary Outcome Measure
时间窗: 28 days
All-cause mortality within 28 days after randomization, defined as the proportion of participants who die from any cause within 28 days of enrollment.
次要结局
- Platelet count(Baseline, Day 3, and Day 7)
- International normalized ratio (INR)(Baseline, Day 3, and Day 7)
- Change in pediatric Sequential Organ Failure Assessment (pSOFA) score(Baseline, Day 1, Day 3, and Day 7)
- Duration of vasopressor support(Up to 28 days)
- Length of pediatric intensive care unit (PICU) stay(Up to 28 days)
- Time to shock resolution(Up to 28 days)
- Change in C-reactive protein (CRP)(Baseline, Day 3, and Day 7)
- Change in procalcitonin concentration(Baseline, Day 3, and Day 7)
- Fibrinogen concentration(Baseline, Day 3, and Day 7)
- Incidence of therapeutic plasma exchange-related adverse events(Up to 28 days)
研究者
Hani Hamed Saad
Lecturer of pediatrics at Faculty of medicine , Menoufia university
Menoufia University