Ultrasound in Undifferentiated Hypotension (US-UHP)

This study is currently recruiting participants.

Verified January 2013 by San Luigi Gonzaga Hospital

Sponsor:

Information provided by (Responsible Party):

Giovanni Volpicelli, San Luigi Gonzaga Hospital

ClinicalTrials.gov Identifier:

NCT01572571

First received: April 4, 2012

Last updated: January 21, 2013

Last verified: January 2013

History of Changes

Purpose

Background

Symptomatic undifferentiated hypotension represents a negative prognostic factor and the strongest predictor of in-hospital mortality.
Misdiagnosis may lead to delayed or incorrect treatment of some life-threatening conditions.

Aim

- The aim of the study is to evaluate the feasibility and accuracy of a new bedside ultrasound method that consists in the focused imaging of the thorax, abdomen and leg veins, in emergency.

Methods

Hypotensive (<100 mm/Hg) patients presenting to our emergency department, complaining of at least one of the neurologic, respiratory and cutaneous signs and symptoms of inadequate tissue perfusion, are prospectively studied by ultrasound-focused assessment of the heart, lungs, inferior vena cava, peritoneum, aorta and leg deep veins.
On the basis of physical examination and ultrasound results, the operator declares the diagnostic hypothesis without influencing the attending physician and the following diagnostic procedure (which includes ultrasound, when needed).
The diagnostic hypothesis is compared with the final diagnosis, obtained after the hospital route and discussed by a panel of three blinded experts (one radiologist, one cardiologist and one emergency physician).
The statistical agreement is calculated by the k of Cohen with p-value, confidence intervals and raw agreement (Ra).

Condition
Hypotension

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Resource links provided by NLM:

MedlinePlus related topics: Low Blood Pressure

U.S. FDA Resources

Further study details as provided by San Luigi Gonzaga Hospital:

Primary Outcome Measures:

Correlation between the ultrasound primary diagnosis and the clinical final diagnosis [ Time Frame: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2011
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients presenting to the Emergency Department with undifferentiated hypotension

Criteria

Inclusion Criteria:

Arterial pressure <100 mm/Hg at presentation
At least one of the following symptoms:
Unresponsive
Syncope
Impaired mental status
Respiratory distress
Severe malaise and fatigue

Exclusion Criteria:

Patients undergoing cardiopulmonary resuscitation
Trauma patients
Electrocardiographic and clinical diagnosis of STEMI or NSTEMI
Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose)
Late evolution of shock state in a patient already treated with known diagnostic tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572571

Contacts

Contact: Giovanni Volpicelli, MD

+39 330 368347

gio.volpicelli@tin.it

Locations

Italy
San Luigi Gonzaga University Hospital, Department of Emergency Medicine	Recruiting
Orbassano, Torino, Italy, 10043
Contact: Giovanni Volpicelli, MD +39 330 368347 gio.volpicelli@tin.it
Contact: Mauro Frascisco, MD +39 335 7274699 mauro.cisco@gmail.com
Principal Investigator: Giovanni Volpicelli, MD
Sub-Investigator: Alessandro Lamorte, MD
Sub-Investigator: Alessandro Mussa, MD
Sub-Investigator: Mattia Tullio, MD

Sponsors and Collaborators

San Luigi Gonzaga Hospital

Investigators

Principal Investigator:

Giovanni Volpicelli, MD

San Luigi Gonzaga Hospital

More Information

Publications:

Atkinson PR, McAuley DJ, Kendall RJ, Abeyakoon O, Reid CG, Connolly J, Lewis D. Abdominal and Cardiac Evaluation with Sonography in Shock (ACES): an approach by emergency physicians for the use of ultrasound in patients with undifferentiated hypotension. Emerg Med J. 2009 Feb;26(2):87-91.

Jones AE, Tayal VS, Sullivan DM, Kline JA. Randomized, controlled trial of immediate versus delayed goal-directed ultrasound to identify the cause of nontraumatic hypotension in emergency department patients. Crit Care Med. 2004 Aug;32(8):1703-8.

Rose JS, Bair AE, Mandavia D, Kinser DJ. The UHP ultrasound protocol: a novel ultrasound approach to the empiric evaluation of the undifferentiated hypotensive patient. Am J Emerg Med. 2001 Jul;19(4):299-302.

Copetti R, Copetti P, Reissig A. Clinical integrated ultrasound of the thorax including causes of shock in nontraumatic critically ill patients. A practical approach. Ultrasound Med Biol. 2012 Mar;38(3):349-59. Epub 2012 Jan 21.

Responsible Party:	Giovanni Volpicelli, Principal Investigator, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:	NCT01572571 History of Changes
Other Study ID Numbers:	SLG-182/2011
Study First Received:	April 4, 2012
Last Updated:	January 21, 2013
Health Authority:	Italy: National Bioethics Committee

Keywords provided by San Luigi Gonzaga Hospital:

Emergency ultrasound
Focused ultrasound
Point-of-care ultrasound
Undifferentiated hypotension

Additional relevant MeSH terms:

Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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