Clinical trial NCT03673891: Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
Official title: Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sepsis
Volume Assessment
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The LifeFlow rapid infusion device is a handheld manually-operated device that has been shown in early trials to increase the rate of bolus fluid infusion up to 3 times the rate of delivery attributed to conventional rapid infusion devices. The device addresses other technical barriers to fluid resuscitation, including reducing complexity and provider fatigue. LifeFlow utilizes standard IV or intraosseous (IO) vascular access devices to quickly and efficiently deliver appropriate volumes of crystalloid fluid to patients during emergent fluid resuscitation. The purpose of this study is to determine if intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current standard techniques in adult patients who present to the Emergency Department with septic shock.

Detailed description: Patients with conditions such as septic shock, anaphylaxis, and hypovolemic shock may require rapid fluid administration to restore blood pressure and tissue perfusion. Newly Updated Surviving Sepsis Campaign (SSC) guidelines call for patients with septic shock to receive a 30ml/kg intravenous (IV) fluid challenge within 1 hour of emergency department (ED) arrival, with improved outcomes shown with early fluid infusion. Patients with shock and severe hypotension may require even more rapid fluid treatment, up to 4ml/kg/min. While excess fluid infusion may be associated with harm, early fluid infusion for the reversal of shock can reduce the need for subsequent interventions, ultimately leading to improved patient outcomes. This may be especially true in patients with hypotension, who are at greater risk of death if not treated quickly, as a single episode of hypotension in patients with sepsis is correlated with a significantly increased risk of death.

In patients who require IV fluid bolus therapy, technical barriers such as slow infusion rates, technically complex infusion devices, and inadequate nursing resources may lead to delay in fluid administration and inadequate resuscitation. As recommended by the SSC guidelines, patients receiving fluid bolus therapy for septic shock require frequent reassessment of clinical response. With current fluid delivery techniques, the ability to reassess quickly and relate fluid administration directly to markers of hemodynamic improvement is limited.

The LifeFlow rapid infusion device is a handheld manually-operated device that has been shown in early trials to increase the rate of bolus fluid infusion up to 3 times the rate of delivery attributed to conventional rapid infusion devices. The device addresses other technical barriers to fluid resuscitation, including reducing complexity and provider fatigue. LifeFlow utilizes standard IV or intraosseous (IO) vascular access devices to quickly and efficiently deliver appropriate volumes of crystalloid fluid to patients during emergent fluid resuscitation.

The purpose of this study is to determine if intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current standard techniques in adult patients who present to the Emergency Department with septic shock.

Primary Hypothesis

* Intravenous fluids can be administered more rapidly and efficiently with the use of the LifeFlow rapid infusion device compared to the current techniques in patients who present to the ED with hypotension and suspected septic shock Secondary Hypotheses
* Hypotensive patients receiving intravenous fluids utilizing the LifeFlow infusion device will have more rapid normalization of vital sign parameters (i.e., resolution of hypotension = MAP 65 mmHg or greater), and more rapid improvement in markers of tissue ischemia (i.e., lactate clearance) than patients receiving fluid using other techniques.
* Based on reduced ICU and hospital length of stay (LOS), the overall cost of treatment will be lower in ED patients receiving early IV fluid resuscitation with LifeFlow comparted to similar patients treated with standard techniques.

Eligibility criteria: Inclusion Criteria:

* Adult ED patients ≥ 18 years of age
* Patients with hypotension (Systolic Blood Pressure (SBP) \< 90) mmHg or Mean Arterial Pressure (MAP) \< 65 mmHg) and at least one of the following:

  * Temperature \> 101 F (38.3 C) or \< 96.8 F (36.0 C)
  * Respiratory Rate (RR) \> 22 bpm
  * Heart Rate (HR) \> 90/min
* Patients who will be determined by treating emergency physician to receive rapid fluid bolus for hypotension
* Patients with adequate cardiac windows
* EF is 35% or greater
* No increased number of B lines per rib interspace (3 or more) in multiple locations on lung ultrasound

Exclusion Criteria:

* Heart failure by history or Ejection fraction (EF) \< 35 percent on pre-enrollment Point of care (POC) Echocardiogram
* History of End stage Renal disease
* History of End stage lung disease
* Lymphocyte count \< 50mm/m3 or Absolute Neutrophil Count \< 500
* Transferred from another facility
* Requirement for immediate surgery
* Patients with 14 Gauge catheters or larger
* Concurrently on vasopressors or inotrope therapy
* Patients or legally acceptable representatives unable to provide consent
* Non-sepsis related primary diagnosis including: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, active gastrointestinal hemorrhage, seizure, drug overdose, burn or trauma, myocardial infarction or active hemorrhage
* Incarcerated patients
* Requirement for immediate surgery
* Known pregnancy

Primary outcomes:
measure: Time of initiation and termination of each fluid bolus administration
timeFrame: Up to 30 days
measure: Volume of each fluid bolus administration
timeFrame: Up to 30 days
Secondary outcomes:
measure: Length of stay in the Emergency department, Intensive care unit, and total hospital length of stay
timeFrame: Up to 30 days
measure: Resolution of abnormal blood pressure (measured at time of arrival, diagnosis and following each fluid bolus)
timeFrame: Up to 30 days
measure: Assessment of Adverse effects, including rate of Intravenous fluid infiltration
timeFrame: Up to 30 days
measure: Time to administration of antibiotics
timeFrame: Up to 30 days
measure: Type of vasopressors used
timeFrame: Up to 30 days
measure: Number of subjects received a central line
timeFrame: Up to 30 days
measure: Need for endotracheal intubation/mechanical ventilation
timeFrame: Up to 30 days
measure: Number of ventilator-free days
timeFrame: Up to 30 days
measure: Time from initial order to completion of first fluid bolus
timeFrame: Up to 30 days
measure: Percent of fluid overload (FO) was calculated using the following formula: [(total fluid intake (L) - total fluid output in liters (L)) / (admission weight in kilograms)*100]
timeFrame: Up to 30 days
measure: Peak Fluid overload-defined as the maximum percentage of fluid overload during the first 72 h after initiation of invasive Mechanical Ventilation
timeFrame: Up to 30 days
measure: Resolution of abnormal heart rate (measured at time of arrival, diagnosis and following each fluid bolus)
timeFrame: Up to 30 days
measure: Time vasopressors are started and discontinued
timeFrame: Up to 30 days
Other outcomes:
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