Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis; Volume Assessment
• Intervention / Treatment: Device: Life Flow

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; After obtaining the consent, the subject will have a bedside ultrasound performed by the study investigator after receiving 500 ml of intravenous fluid bolus. The images will be recorded on ultrasound machine hard drive for future review. If the bedside ultrasound findings determine that the subject is not fluid responsive, subjects will be excluded from the study. If the subject is determined to be fluid responsive, the above listed outcome measures will be collected. Ultrasound will be repeated after every 500 ml bolus if the patient continues to receive IV fluids which will be determined by the treating physician. Ultrasound measurements and other parameters listed above will be collected throughout the ED and hospital stay.
Experimental: LifeFlow group; LifeFlow device will be used to administer intravenous fluids in this group. LifeFlow is a FDA approved device to administer IV fluids. Subject will have a bedside ultrasound performed by the study investigator after receiving 500 ml of intravenous fluid bolus. The images will be recorded on ultrasound machine hard drive for future review. If the bedside ultrasound findings determine that the subject is not fluid responsive, subjects will be excluded from the study. If the subject is determined to be fluid responsive, the above listed outcome measures will be collected. Ultrasound will be repeated after every 500 ml bolus if the patient continues to receive IV fluids which will be determined by the treating physician. Ultrasound measurements and other parameters listed above will be collected throughout the ED and hospital stay.	Device: Life Flow; LifeFlow device will be used to administer intravenous fluids in this group. LifeFlow is a FDA approved device to administer IV fluids. Subject will have a bedside ultrasound performed by the study investigator after receiving 500 ml of intravenous fluid bolus. The images will be recorded on ultrasound machine hard drive for future review. If the bedside ultrasound findings determine that the subject is not fluid responsive, subjects will be excluded from the study. If the subject is determined to be fluid responsive, the above listed outcome measures will be collected. Ultrasound will be repeated after every 500 ml bolus if the patient continues to receive IV fluids which will be determined by the treating physician. Ultrasound measurements and other parameters listed above will be collected throughout the ED and hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time of initiation and termination of each fluid bolus administration	Up to 30 days
Volume of each fluid bolus administration	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the Emergency department, Intensive care unit, and total hospital length of stay		Up to 30 days
Resolution of abnormal blood pressure (measured at time of arrival, diagnosis and following each fluid bolus)		Up to 30 days
Assessment of Adverse effects, including rate of Intravenous fluid infiltration		Up to 30 days
Time to administration of antibiotics		Up to 30 days
Type of vasopressors used	Epinephrine vs. Dopamine vs. Dobutamine vs. Norepinephrine	Up to 30 days
Number of subjects received a central line		Up to 30 days
Need for endotracheal intubation/mechanical ventilation		Up to 30 days
Number of ventilator-free days		Up to 30 days
Time from initial order to completion of first fluid bolus		Up to 30 days
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]		Up to 30 days
Peak Fluid overload-defined as the maximum percentage of fluid overload during the first 72 h after initiation of invasive Mechanical Ventilation		Up to 30 days
Resolution of abnormal heart rate (measured at time of arrival, diagnosis and following each fluid bolus)		Up to 30 days
Time vasopressors are started and discontinued		Up to 30 days

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 188903474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No