SepsisNCT03673891
Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
A study testing Life Flow in people with Sepsis and Volume Assessment, run by University of Arizona.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Volume Assessment
- What is being tested?
- Life Flow
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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.
Read the 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.
- Conditions
- Sepsis, Volume Assessment
- Being tested
- Life Flow
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life FlowDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Life Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of initiation and termination of each fluid bolus administration
Measured: Up to 30 days
Volume of each fluid bolus administration
Measured: Up to 30 days
Secondary outcomes (13)
Length of stay in the Emergency department, Intensive care unit, and total hospital length of stay
Measured: Up to 30 days
Resolution of abnormal blood pressure (measured at time of arrival, diagnosis and following each fluid bolus)
Measured: Up to 30 days
Assessment of Adverse effects, including rate of Intravenous fluid infiltration
Measured: Up to 30 days
Time to administration of antibiotics
Measured: Up to 30 days
Type of vasopressors used
Epinephrine vs. Dopamine vs. Dobutamine vs. Norepinephrine
Measured: Up to 30 days
Number of subjects received a central line
Measured: Up to 30 days
Need for endotracheal intubation/mechanical ventilation
Measured: Up to 30 days
Number of ventilator-free days
Measured: Up to 30 days
Time from initial order to completion of first fluid bolus
Measured: 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]
Measured: 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
Measured: Up to 30 days
Resolution of abnormal heart rate (measured at time of arrival, diagnosis and following each fluid bolus)
Measured: Up to 30 days
Time vasopressors are started and discontinued
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Jan 2019
- Primary completion1 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srikar Adhikari, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673891
- Sponsor's protocol ID
- 188903474
- Status last verified
- Jul 2019
- First submitted
- 12 Sep 2018
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluid Infusion With LifeFlow for Patients With Suspected Septic Shock
- ClinicalTrials.gov ID
- NCT03673891
- Acronym / sponsor ID
- 188903474
- Conditions
- Sepsis, Volume Assessment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Life FlowLifeFlow 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life FlowLifeFlow 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 | LifeFlow group |
Primary outcome
Time of initiation and termination of each fluid bolus administration
Time frame: Up to 30 days
Volume of each fluid bolus administration
Time frame: Up to 30 days
13 secondary outcomes
Length of stay in the Emergency department, Intensive care unit, and total hospital length of stay
Time frame: Up to 30 days
Resolution of abnormal blood pressure (measured at time of arrival, diagnosis and following each fluid bolus)
Time frame: Up to 30 days
Assessment of Adverse effects, including rate of Intravenous fluid infiltration
Time frame: Up to 30 days
Time to administration of antibiotics
Time frame: Up to 30 days
Type of vasopressors used
Time frame: Up to 30 days
Number of subjects received a central line
Time frame: Up to 30 days
Need for endotracheal intubation/mechanical ventilation
Time frame: Up to 30 days
Number of ventilator-free days
Time frame: Up to 30 days
Time from initial order to completion of first fluid bolus
Time frame: 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]
Time frame: 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
Time frame: Up to 30 days
Resolution of abnormal heart rate (measured at time of arrival, diagnosis and following each fluid bolus)
Time frame: Up to 30 days
Time vasopressors are started and discontinued
Time frame: Up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Life Flow in people with Sepsis and Volume Assessment, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of initiation and termination of each fluid bolus administration (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.