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Completed

NCT Number: NCT01572571

Ultrasound in Undifferentiated Hypotension

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).

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Luigi Gonzaga University Hospital, Department of Emergency Medicine

Orbassano, Torino, 10043, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension

Acronym: US-UHP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2012
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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