Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 23
- 主要终点
- Fluid Balance
研究概览
简要总结
This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.
详细描述
Multi-center randomized study comparing dynamic assessment of fluid responsiveness utilizing Starling SV monitor compared to a control group.
Subjects will be randomized in a 2:1 treatment to control group ratio to increase power for sub-analysis by patient population.
Patients randomized to the Starling SV arm will have treatment guided by a dynamic assessment of fluid responsiveness (measured by a change in stroke volume index > 10%) as assessed by passive leg raise (PLR).
Patients randomized to the control group will receive standard of care treatment.
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
- •Diagnosis of sepsis, as exhibited by 2 or more of the following systemic inflammatory response syndrome (SIRS) criteria and a known or presumed infection at time of screening:
- •Temperature of > 38 C or < 36 C
- •Heart rate of > 90/min
- •Respiratory rate of > 20/min or PaCO2 < 32 mm Hg (4.3 kPA)
- •White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands
- •Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
- •Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
- •Anticipated ICU admission
- •Able to provide signed informed consent or consent can be obtained from the patient's authorized representative
排除标准
- •Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
- •Known aortic insufficiency, or aortic abnormalities
- •Hemodynamic instability due to active gastrointestinal hemorrhage
- •Patient has received >3 liters of IV fluid prior to study randomization
- •Requires immediate surgery
- •Patient transferred to the ICU from another hospital unit
- •Do not attempt resuscitation (DNAR or DNR) order
- •Advanced directives restricting implementation of the resuscitation protocol
- •Contraindication to blood transfusion
- •Attending clinician deems aggressive resuscitation unsuitable
- •Transferred from another in-hospital setting
- •Not able to commence treatment protocol within 1 hour after randomization
- •Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
- •Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
- •Seizure in the last 24 hours
- •Known allergy to sensor material or gel
- •Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots
- •Patient has an epidural catheter in place
- •Suspected intra-abdominal hypertension
- •Inability to obtain IV access
- •Diabetic ketoacidosis
- •Hyper-osmolarity syndrome
- •Patient uncouples from treatment algorithm
- •Patient should be excluded based on the opinion of the Clinician/Investigator
结局指标
主要结局
Fluid Balance
时间窗: 72 hours
Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.
次要结局
- Percentage of Participants Requiring Renal Replacement Therapy(Day 1 to Day 30)
- Percentage of Participants Requiring Ventilator Use(Day 1 to Day 30)
- Number of Hours of Ventilator Use(Day 1 to Day 30)
- Number of Hours of Vasopressor Use(Day 1 to Day 30)
- Length of ICU Stay(Day 1 to Day 30)
- Change From Baseline in Serum Creatinine Levels at 72 Hours(Baseline, 72 hours)