Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stroke Volume Change
研究概览
简要总结
The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus.
详细描述
The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output detector system. The Starling SV system measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.
This study is a prospective feasibility study. Patients will be evaluated by the Emergency Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Criteria
- •SBP <90 or BP rapidly trending lower
- •Secondary Criteria
- •Low urine output Acute change in urine output less than 50ml/4 hours
- •Persistent hyperlactatemia
- •A new vasopressor started
- •Acute change in HR less than 50 or greater than 120
- •New onset chest pain or chest pain different then admission assessment
- •Acute bleeding
- •Fever > 39 degrees
- •Significant change in mental status: confusion, agitation, delirium, etc.
- •Unexplained lethargy
- •CRT >2 seconds -
排除标准
- •Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
- •Known aortic insufficiency, or aortic abnormalities
- •Requires immediate surgery
- •Advanced directives restricting implementation of the resuscitation protocol
- •Known intraventricular heart defect, such as VSD or ASD
- •Known allergy to sensor material or gel
- •Suspected intra-abdominal hypertension
- •Inability to obtain IV access
- •Patient should be excluded based on the opinion of the Clinician/Investigator
- •Patient has an unstable airway
结局指标
主要结局
Stroke Volume Change
时间窗: During fluid bolus
Change in stroke volume following the administration of each 500 cc fluid bolus.
次要结局
- MACE(28 days)
- Discharge Location(Up to 180 days from hospital admission)
- Fluid Input and Output in ICU(28 days)
- Mortality(28 days)
- Fluid Input and Output(72 hours)
- LOS in ICU(Up to 180 days from ICU admission)
- Mechanical ventilation(28 days)
- Adverse Events(28 days)
- Stroke Volume Difference(during fluid bolus)
- Vasopressor Use(28 days)
- Serum Creatinine Levels(28 days)
- Renal Replacement Therapy(28 days)
研究者
Ivor Douglas
Chief of Pulmonary and Medical Critical Care
Denver Health and Hospital Authority