Ultrasound in Undifferentiated Hypotension (US-UHP)

• ClinicalTrials.gov Identifier: NCT01572571
• Recruitment Status: Completed
• First Posted: April 6, 2012
• Last Update Posted: December 19, 2013
• Sponsor: San Luigi Gonzaga Hospital
• Information provided by (Responsible Party): Giovanni Volpicelli, San Luigi Gonzaga Hospital

Study Description

Brief Summary:

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 or disease
Hypotension

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension
• Study Start Date: December 2011
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Italy

San Luigi Gonzaga University Hospital, Department of Emergency Medicine

Orbassano, Torino, Italy, 10043

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. doi: 10.1136/emj.2007.056242.

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. doi: 10.1016/j.ultrasmedbio.2011.11.015. Epub 2012 Jan 21. Review.

• Responsible Party: Giovanni Volpicelli, Principal Investigator, San Luigi Gonzaga Hospital
• ClinicalTrials.gov Identifier: NCT01572571
• Other Study ID Numbers: SLG-182/2011
• First Posted: April 6, 2012
• Last Update Posted: December 19, 2013
• Last Verified: December 2013

Keywords provided by Giovanni Volpicelli, San Luigi Gonzaga Hospital:

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

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases