Personalized Fluid Resuscitation for Improved Sepsis Resuscitation Quality in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.
详细描述
We will conduct a single-center pilot feasibility trial comparing a dynamic fluid assessment using non-invasive cardiac output monitoring (NICOM) vs usual care in 40 patients with sepsis in the Emergency Department (ED). The trial will enroll patients with suspected sepsis and hypotension or lactate ≥4 mmol/L who have not received 30 ml/kg initial IV fluid. Patients will be randomized 3:1 to receive a NICOM fluid assessment vs standard care. The NICOM fluid assessment will involve measuring stroke volume change during a passive leg raise using NICOM. Results will be provided to the ED treating team. The primary outcome will be IV fluid received within 3 hours. Secondary outcomes include sepsis bundle compliance and feasibility and acceptability of the NICOM assessment (assessed via clinician survey).
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 patient being treated in the Intermountain Medical Center ED
- •Patient has suspected sepsis. Suspected sepsis can be identified by a positive sepsis screen (standard screen completed by ED triage nurse), an active sepsis alert (which is triggered based on qualifying information or active by an ED nurse), or clinician report that patient has possible sepsis
- •Patient is hypotensive OR has an initial lactate ≥4 mmol/L at the time of enrollment. Hypotension is defined as mean arterial pressure (MAP) <65 mmHg or systolic blood pressure (SBP) <90mmHg or patient is on vasopressors at time of enrollment.
排除标准
- •Age < 18 years
- •Known pregnant patients
- •Patients who are known to be incarcerated
- •A trained and delegated study team member is not available to perform the NICOM fluid assessment
- •Patient has been in the ED for >6 hours or was transferred from an outside ED
- •Patient has already received 30 ml/kg IV fluid or has this fluid volume ordered. Weight-based fluid dosing is calculated based on actual body weight for BMI <30kg/m2 and ideal body weight for BMI ≥30 kg/m2
- •Known clinical diagnosis of a condition potentially altering risk/benefit profile of NICOM-based fluid assessment, which may include
- •Hemorrhagic shock (i.e.., active hemorrhage)
- •Cardiogenic shock (i.e., hypotension suspected to be due to left or right ventricular failure)
- •Obstructive shock (i.e., shock in the setting of known acute central pulmonary embolism, pneumothorax, or pericardial effusion)
- •Active volume loss that requires fluid replacement per the treating clinician (i.e., injury due to burn)
- •Acute stroke
- •Acute myocardial infarction
- •Status asthmaticus
- •Status epilepticus
- •Presence of a left ventricular assist device (LVAD)
- •Severe aortic insufficiency
- •Known clinical contraindication to passive leg raise.
- •Lower extremity amputation
- •Lower extremity trauma
- •Open abdomen
- •Suspected or known elevated intracranial pressure, for example from intracranial hemorrhage, tumor, or traumatic brain injury
- •Contraindication to lying flat
- •Inability to cooperate with the maneuver (e.g., severe pain, agitation).
- •Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.
- •Allergy to adhesive used in the NICOM lead stickers
- •Skin breakdown precluding lead placement on the patient's chest and back
- •Treating clinician determines that NICOM assessment is either required or contraindicated for the optimal care of the patient
研究组 & 干预措施
NICOM Fluid Assessment
NICOM fluid assessment
干预措施: Non-Invasive Cardiac Output Monitoring (NICOM) (Other)
Usual Care
Participants will not receive any research intervention
结局指标
主要结局
Primary Outcome
时间窗: 3 hours
IV Fluid volume received within 3 hours of enrollment
IV fluid volume (3-hour)
时间窗: 3 hours
Total volume of IV resuscitative fluids received within 3 hours of enrollment. This will be measured as total volume and as a weight-based measure in mL/kg (using actual weight up to BMI 30 and ideal body weight for patients with BMI \>=30).
次要结局
- Sepsis bundle compliance (3-hour)(3 hours)
- Sepsis bundle compliance (6-hour)(6 hours)
- Feasibility(Day 1)
- Acceptability(Day 1)
- IV Fluid Volume (6 hour)(6 hours)
- Utility of intervention(Day 1)