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

NCT03673891 | Withdrawn

• 1 other identifier: 188903474
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Volume Assessment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

  Up to 30 days

Study Arms (2)

Control

NO INTERVENTION

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.

LifeFlow group

EXPERIMENTAL

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

Interventions

Life Flow DEVICE

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.

LifeFlow group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: January 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2019
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share