Venous Excess Ultrasound (VEXUS)-Guided Management Versus Usual Care in Patients with Septic Shock: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The goal of this pilot clinical trial is to determine if conducting a larger study using venous excess ultrasound (VEXUS) to guide fluid management in patients with septic shock is feasible. Septic shock is a life-threatening condition where infection causes dangerously low blood pressure. While fluids are essential for treatment, too much fluid can harm the kidneys and result in the need for dialysis. The main questions it aims to answer are:
- Is it feasible to recruit patients, obtain consent, and follow the VEXUS-guided management protocol?
- Does VEXUS-guided management, compared with usual care, improve the health and well-being of patients with septic shock?
Researchers will compare two groups: one receiving VEXUS-guided fluid management versus another receiving standard care, to assess the feasibility of a larger trial and explore whether VEXUS prevents fluid overload and kidney problems.
Participants in the VEXUS group will:
- Undergo VEXUS scans every 24 hours for 3 days
- Receive fluid management guided by VEXUS findings (including fluid restriction or removal if we identify venous congestion) and undergo cardiac ultrasound if we identify moderate to severe congestion
- Be monitored for 28 days to track kidney function, need for dialysis, and survival.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years)
- •Within 12 hours of meeting septic shock diagnosis based on following Sepsis-3 criteria: requirement for vasopressors to maintain organ perfusion, lactate > 2 mmol/L, and suspected or confirmed infection)
- •Within 48 hours of intensive care unit admission.
排除标准
- •Already receiving renal replacement therapy
- •Patients for whom a decision to initiate renal replacement therapy has been made prior to study enrolment
- •Patients who have limitations on medical therapy or restrictions on goals of care
- •Active bleeding causing hemodynamic instability
- •Veno-venous or veno-arterial extracorporeal membrane oxygenation
- •Previously enrolment in study
- •10% or more of body surface area acute burn injury
- •Suspected or confirmed liver cirrhosis
- •Established allergy to sulfa drugs;
- •Patients receiving treatments that require continuous IV fluid infusions (e.g., diabetic ketoacidosis, diabetes insipidus)
- •Unable to measure fluid balance accurately
- •Contra-indication to study recommended interventions (e.g., diuretics, inotropes)
- •Unable to perform VEXUS due to anatomical barriers (e.g., surgical dressings);
- •Unable to complete VEXUS scan during the 6-hour resuscitation window
- •Moderate to Severe Tricuspid Regurgitation
- •Untreated Metabolic/biochemical findings (Hypokalemia [K+]< 3.0 mmol/L; metabolic alkalosis [Bicarbonate > 40 mmol/L and/or pH > 7.55], Hypomagnesemia [Mg2+] < 0.6, and Hypernatremia [Na+] > 155 mmol/L)
结局指标
主要结局
Recruitment Rate
时间窗: Up to 160 weeks
Number of participants enrolled during the recruitment period who successfully complete study procedures and follow-up.
次要结局
- Consent rate(From enrollment to the end of the study period at 28 days)
- VEXUS scan completion rate(From enrollment to the end of treatment period at 3 days)
- Protocol Adherence(From enrollment to the end of treatment period at 3 days)
研究者
John Basmaji
Critical Care Physician
Western University, Canada