The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Inpatient mortality in both treatment arms.
研究概览
简要总结
The aim of the study is to identify the diagnostic value of the focused assessed echocardiography in septic patients undergoing urgent abdominal surgery due to peritonitis. The investigators expect that the incidence of hemodynamic instability will be reduced and the survival of the patients will be improved.
详细描述
Often sepsis remains undiagnosed at the very beginning because of the concentration to the surgical pathology in perioperative period. This results in unacceptably high mortality. The investigators hypothesize that extended hemodynamic monitoring by focused transthoracic echocardiography will personalize early fluid resuscitation which will improve patient's outcome.
The goals of the investigators study are:
- To conduct two-group randomized controlled clinical trial to compare patient management based on standard monitoring and extended hemodynamic monitoring by focused transthoracic echocardiography in patients undergoing urgent abdominal surgery due to peritonitis.
- To demonstrate that patient management based on extended hemodynamic monitoring by focused echocardiography results in improved survival, reduced incidence of hemodynamic instability during perioperative period.
- To compare an amount of administrated of intravenous fluids in both groups.
The investigators hypothesize that focused echocardiography monitoring will result in more administrated intravenous fluids during perioperative period.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years old.
- •Patients undergoing urgent abdominal surgery due to diffuse peritonitis.
- •SOFA score >
- •Patients who sign an agreement to participate in the study.
排除标准
- •Younger than 18 years old.
- •Known pregnancy.
- •Unconscious patients or those who do not agree to participate in the study.
- •Contraindication to central venous or arterial catheterization.
- •Patients who were already treated in ICU because of sepsis or septic shock before this surgery.
- •Known chronic renal failure.
- •Re-laparotomy.
- •Peritonitis due to acute mesenteric ischaemia, thrombosis or trauma.
- •Dying patients.
研究组 & 干预措施
Non-echo group
Patients get the standard monitoring and treatment based on Good medical practice. Extended monitoring by focused echocardiography is not applied for this group.
Focussed echocardiography group
The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.
干预措施: Focused assessed echocardiography (Other)
结局指标
主要结局
Inpatient mortality in both treatment arms.
时间窗: 30 days intra-hospital mortality
Comparison of 30 days intra-hospital mortality in both arms.
次要结局
- Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).(up to 24 hours)
- Number of ICU-Free days.(up to 30 days)
- Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.(1-5 minutes after anaesthesia induction.)
- Comparison of septic shock incidence in both arms.(up to 30 days)
研究者
Asta Maculiene
Principal Investigator
Lithuanian University of Health Sciences