Ultrasound in Undifferentiated Hypotension (US-UHP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Volpicelli, San Luigi Gonzaga Hospital
ClinicalTrials.gov Identifier:
NCT01572571
First received: April 4, 2012
Last updated: December 18, 2013
Last verified: December 2013
  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:


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 ]

Enrollment: 100
Study Start Date: December 2011
Study Completion Date: December 2013
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
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: December 18, 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 August 26, 2014