Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SOFA score
研究概览
简要总结
Postpartum sepsis is widely known as a preventable main cause of maternal morbidity and mortality. According to the World Health Organization, approximately 11% of the estimated maternal deaths worldwide were attributed to sepsis. Recent global assessments indicate that obstetric infections rank as the third most prevalent cause of maternal death, with a prevalence mainly observed in low- and middle-income nations.
详细描述
The management of septic shock is a major medical concern. Early goal-directed therapy emerged as a novel approach for reducing sepsis mortality and was incorporated into Surviving Sepsis Campaign guidelines in 2012. Early detection of sepsis, rapid initiation of antibiotics and effective resuscitation with fluids, vasopressors, and inotropes were important concerns. However, many randomized trials were done to examine the effect of EGDT on morbidity and mortality and showed that EGDT was not associated with a significant reduction in mortality in patients with septic shock compared to usual care. That it wasn't addressed in recent guidelines in 2016 and 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postpartum women, within 6 weeks following delivery
- •meeting the third international consensus definitions for septic Shock (2016) (Sepsis-3): acute persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and having a serum lactate > 2 mmol/L (18 mg/dL) despite adequate volume resuscitation
排除标准
- •Patient refusal
- •History of any chronic cardiac disease
- •Requirement for immediate surgery
- •Hypotension attributable to another cause
- •Do-not-resuscitate status
- •Contraindication to central venous catheter placement
- •Difficult transthoracic echocardiographic evaluation
- •Primary cardiogenic cause of shock, instead of sepsis.
研究组 & 干预措施
CTGT group
a clinically guided resuscitation protocol, derived from EGDT
干预措施: a clinically guided resuscitation protocol, (Procedure)
ECHO group
a transthoracic bedside focused echocardiographic assessment of the patient
干预措施: a transthoracic bedside focused echocardiographic assessment (Procedure)
结局指标
主要结局
SOFA score
时间窗: 48 hours.
The change in Sequential Organ Failure Assessment (SOFA score)
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University