Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03285269 |
| Other study ID # |
ERUSH-001 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2017 |
| Est. completion date |
November 2018 |
Study information
| Verified date |
January 2022 |
| Source |
Kaiser Permanente |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The current study plants to create a patient registry of patients who present to the
emergency department with signs and symptoms of shock and evaluate the ability of a
multi-step cardiopulmonary ultrasound protocol to determine the need for fluid therapy.
Description:
Background & Motivation: Non-traumatic shock accounts for millions of emergency department
visits every year and is a significant burden on the health care system making rapid
identification and treatment essential. For decades the Rapid Ultrasound in Shock and
Hypotension (RUSH) exam has been employed to help determine the etiology of non-traumatic
shock in the ED setting. The RUSH exam does not answer other critical questions such as the
need for additional fluid resuscitation. The current study hypothesizes that by include a
step-wise cardiopulmonary algorithm the RUSH exam can be extended (E-RUSH) to accurately
determine the need for additional fluid therapy.
Study Design: Prospective Observational Study in two urban Emergency Departments with a
combined annual census of >111,000.
Population: ED patients exhibiting signs of shock definied by a systolic blood pressure < 100
mmhg, MAP < 65, persistent tachycardia, mottled skin, or lactate >2mmol either at
presentation or during ED stay will be included. Exclusion criteria will be inability to
consent, external factors preventing ultrasound examination, age less than 18, pregnancy,
incarceration, arrhythmia, cardiac arrest, or treating physician gestalt that the patient is
not in shock.
Protocol: The E-RUSH protocol will include ultrasound exams of the IVC, heart and lungs as
described in the RUSH protocol but will also evaluate cardiac output, IVC collapsibility, and
presense of B-lines on lung ultrasound. At the time of ultrasound measuresments a
bioreactance device will be applied. Bioreactance measurements and ultrasound measurement of
cardiac output will be recorded pre and post a passive straight leg raise test. All charts
will be reviewed by two experts who are blinded to ultrasound and bioractance measurements.
When possible the protocol will be repeated 1-2 hours later or after initial interventions in
order to provide trend data.
Data Analysis: Volume responsivness as assessed by the E-RUSH will be defined a priori using
a step-wise flow diagram that combines IVC, lung and cardiac ejection fraction and output
measurements (see research plan for details). Determination of volume responsiveness by the
bioreactance device will be defined by manufacturer protocal. Determination of volume
responsiveness by expert review will be by a standard abstraction form with agreement of both
expert reviewers. Descriptive statistics will be performed to determine the test
characteristics of the ultrasound protocol to predict volume responsiveness. Given the lack
of a universally agreed upon gold standard for volume responsiveness, we will determine test
characteristics for E-RUSH using the bioreactance device as a reference standard and using
expert review as a second reference standard separately.
FACILITY RESOURCES The study facilities are in San Diego California, with a combined
emergency department census of over 111,000 patients per year. The emergency departments of
the facilities are equipped with portable bedside ultrasound machines, CT and MRI, 24 hour
laboratory testing and an integrated electronic medical record system. Emergency medicine and
family medicine residents rotate through both emergency departments. Both departments are
stroke receiving centers and level 3 trauma centers.
Research Databases An important aspect of the KPSC managed care environment is its integrated
approach to the delivery of medical care. This approach depends on, and therefore
facilitates, the development and maintenance of a large number of databases, linkable through
a unique identification key. These databases include those that track membership, encounters,
laboratory, claims, pharmaceutical dispensations and others. The address information is
annually geo-coded to the census block level, providing linkage to census-based group-level
information about socio-economic status.
Each of the KPSC clinical operations systems are updated in real-time, facilitating our
ability to create near real-time research databases. Our Membership database captures
demographic (e.g., name, date of birth, gender, race/ethnicity, etc.) and benefit information
for over 12 million active and former members, and is updated on a weekly basis. The
utilization database captures outpatient and hospital encounters (e.g., diagnoses,
procedures, etc.), member claims submitted from outside hospitals (usually with up to 3-month
delay), and care provided at home, skilled nursing and hospice facilities. This database is
updated weekly. Outpatient and inpatient pharmacy databases track medication orders and
dispenses, and are updated either daily or monthly depending on the source system. Death
information is derived from multiple sources including KP hospital and membership data, as
well as two external sources from California State and Social Security Administration death
files. The state death records lag about one to two years for date and underlying cause of
death and between two and three years for all causes listed on the death certificate.
SCIENTIFIC ENVIRONMENT Biostatistical expertise is provided by a Biostatistics Unit that
consists of statisticians, programmers, natural language specialists, database developers and
administrators. The Unit provides services including statistical consultation, data analysis,
data extraction, disease identification based on free-texts and data management for research
projects. In addition, the Unit is responsible for creating many of the research data bases
used. All Unit employees have SAS programming skills and years of experience in conducting
broad and varied research. The Biostatistics Unit supports more than 300 research projects
annually.
Oversight of Research at KPSC KPSC has an Institutional Review Board (IRB) under the Medical
Director of Operations for the Southern California Permanente Medical Group. The IRB is
charged with the protection of human subjects through the oversight of all investigators and
their research projects in Kaiser Permanente Southern California. Compliance with the minimum
Federal standards for the protection of human subjects in research is demonstrated by a
Federal Wide Assurance (FWA) held through the Kaiser Foundation Research Institute. The IRB
also acts as the KPSC HIPAA privacy board.
Ethics Kaiser Permanente - Southern California (KPSC) shall obtain written evidence of review
and approval from our independent ethics committee (IRB) of the protocol, informed consent
forms, evidence of partial waiver, and all other documents requiring IRB review and approval
prior to the initiation of the project.
1. RISKS TO THE SUBJECTS
1. Human Subjects Involvement and Characteristics Describe the proposed involvement of
human subjects in the work outlined in the Research Design and Methods section.
The study population are ED patients exhibiting signs of shock definied by a
systolic blood pressure < 100 mmhg, MAP < 65, persistent tachycardia, mottled skin,
or lactate >2mmol either at presentation or during ED stay will be included.
Exclusion criteria will be inability to consent, external factors preventing
ultrasound examination, age less than 18, pregnancy, incarceration, traumatic
mechanism, arrhythmia, cardiac arrest, or treating physician gestalt that the
patient is not in shock. Our goal is to enroll a total of 50 patients.
This study will not recruit subjects defined as vulnerable populations. Individuals
age less than 18 and pregnant women will be excluded as noted in the exclusion
criteria.
2. Sources of Materials
The following data will be obtained from the patient:
- Consent Form
- ultrasound will be used to perform visual assessment of the patient's inferior vena
cava
- Variables including but not limited to: systolic blood pressure, MAP, persistent
tachycardia, mottled skin, or lactate status, age, pregnancy status, arrhythmia,
cardiac arrest,
- "Electronic Health Data" - All charts will be reviewed by two experts who are
blinded to ultrasound and bioractance measurements.
- Bioreactance measurements and ultrasound measurement of cardiac output will be
recorded pre and post a passive straight leg raise test.
The data collected will be linked/coded using a study identification number (SID) and
only KPSC study team members and persons directly involved in recruitment will have
access to the key that identifies individual subjects.
2. ADEQUACY OF PROTECTION AGAINST RISKS
1. Recruitment and Informed Consent We will obtain a waiver to access and use the EHR
data for case/patient identification. The waiver will be used to identify patients
in order approach patients regarding the study and to obtain consent. Study
personnel will screen the ED tracking board and communicate with ED providers to
find patients meeting inclusion criteria. Upon identification study personnel, will
approach patient in the private exam room to obtain informed consent in person.
The study will not recruit anyone less than 18 or women who are pregnant. However,
due to the rich diversity of Kaiser Permanente's membership in Southern California,
Spanish speakers will be recruited. All materials and forms will be translated to
Spanish to include all Spanish speaking/reading potential participants. Consent
forms will be stored securely onsite and a study database will be maintained. All
patients will be provided a copy of the consent form.
2. Protection Against Risk Names and other identifying information on participants
will be obtained for record keeping purposes only and no participants will be
identified in any forms or reports from this study. Survey and clinical data will
only be shared internally among KPSC study team members and only persons directly
involved in recruitment will have access to the key that identifies individual
subjects. Transfer of data if needed will be via encrypted email.
3. POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS The immediate
benefit to the participant is none. However, If the E-RUSH protocol proves accurate and
useful, it has the potential to improve patient care and safety and a vulnerable and
high risk population. There are no high-risk aspects of the proposed work.
4. IMPORTANCE OF THE KNOWLEDGE TO BE GAINED There are no high-risk aspects of the proposed
work. The importance of the current study presents an innovative algorithm that my
further demonstrate the ability of ultrasound to be useful in the shock patient to
determine fluid needs. If an algorithmic approach using bedside ultrasound proves
accurate in titrating fluid resuscitation, it could reduce complications of under
resuscitation (organ failure) and over resuscitation (pulmonary edema, third spacing and
abdominal compartment syndrome). Avoidance of complications would have downstream
benefits such as reduced length of stay, reduced mortality, and reduced burden on the
healthcare system.
5. DATA AND SAFETY MONITORING PLAN Our study will not be a clinical trial. All the
information and/or databases will be password protected to ensure security of the PHI
contained in the data systems. Study data access that would identify participants will
be tightly controlled and limited to authorized individuals using the follow safeguards:
roles and privileges, defined data owners, automatic log off and lockouts, field level
hide, read only, or read-write permission at user level, encryption of data transfers,
and limited/controlled delete capabilities. Standard backup procedures will be employed
at Kaiser Permanente, where data will be backed up nightly to a secured disk based
storage system and then offloaded to a robotic tape library system, with tapes rotated
offsite for additional level of protection. This ensures against data loss in the event
of a local systems failure or natural disaster.
