Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- weight gain
研究概览
简要总结
A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department.
Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.
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
- •All patients >18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.
排除标准
- •> 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure>20 cm H2O.
- •Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding.
- •Serious adverse events:
- •Trombosis in arteria femoralis. Death during the study period.
研究组 & 干预措施
Passive Leg Raising
Before decision on fluid administration a passive leg raising test is performed. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.
干预措施: Passive Leg Raising Test (Procedure)
Standard of care
Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.
干预措施: Standard of care (Procedure)
结局指标
主要结局
weight gain
时间窗: 3 days
次要结局
- Cumulative fluid balance study day 1,2,3(Study day 1,2,3)
- ICU length of stay(measured within 90 days after inclusion)
- 30 day mortality(30 days from inclusion in the study)
- Organ support during ICU stay(ICU-stay)
- ICU discharge status(End of ICU stay)
研究者
Christer Svensen
Professor
Karolinska Institutet