NCT03285269

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

September 14, 2017

Last Update Submit

January 6, 2022

Conditions

Shock

Keywords

shockultrasound

Outcome Measures

Primary Outcomes (1)

  • Test Characteristics of the E-RUSH Protocol to Predict Fluid Responsiveness

    Will determine sensitivity and specificity of a step-wise cardiopulmonary approach to determine fluid responsivness.

    1 year

Study Arms (1)

Shock Group

Patients presenting with signs and symptoms of shock will undergo the E-RUSH ultrasound protocol and bioreactance before and after a passive leg raise maneuver.

Diagnostic Test: Ultrasound ProtocolDevice: BioreactanceProcedure: Passive Leg Raise

Interventions

Ultrasound ProtocolDIAGNOSTIC_TEST

Ultrasound of the inferior vena cava, heart and lungs.

Shock Group
BioreactanceDEVICE

Bioreactance assessment using Cheetah Bioreactance Device (FDA Approved). Bioreactance is a non-invasive measure of cardiac output.

Shock Group
Passive Leg RaisePROCEDURE

A passive leg raise involves placing the patient supine and raising the legs to simulate an intravenous fluid bolus.

Shock Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the one of two urban emergency department with signs and symptoms of shock.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

    PMID: 11445675BACKGROUND

  • Bentzer P, Griesdale DE, Boyd J, MacLean K, Sirounis D, Ayas NT. Will This Hemodynamically Unstable Patient Respond to a Bolus of Intravenous Fluids? JAMA. 2016 Sep 27;316(12):1298-309. doi: 10.1001/jama.2016.12310.

    PMID: 27673307BACKGROUND

  • Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011 Feb;39(2):259-65. doi: 10.1097/CCM.0b013e3181feeb15.

    PMID: 20975548BACKGROUND

  • Corl KA, George NR, Romanoff J, Levinson AT, Chheng DB, Merchant RC, Levy MM, Napoli AM. Inferior vena cava collapsibility detects fluid responsiveness among spontaneously breathing critically-ill patients. J Crit Care. 2017 Oct;41:130-137. doi: 10.1016/j.jcrc.2017.05.008. Epub 2017 May 12.

    PMID: 28525778BACKGROUND

  • Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.

    PMID: 27858374BACKGROUND

  • Oord M, Olgers TJ, Doff-Holman M, Harms MP, Ligtenberg JJ, Ter Maaten JC. Ultrasound and NICOM in the assessment of fluid responsiveness in patients with mild sepsis in the emergency department: a pilot study. BMJ Open. 2017 Jan 27;7(1):e013465. doi: 10.1136/bmjopen-2016-013465.

    PMID: 28132006BACKGROUND

  • Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

    PMID: 11794169BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason M Fields, MD

    Kaiser Permanenete

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 18, 2017

Study Start

November 1, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Not planning to share IPD