HypotensionUS-UHPNCT01572571
Ultrasound in Undifferentiated Hypotension
An observational study of Hypotension, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypotension
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to the Emergency Department with undifferentiated hypotension
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
San Luigi Gonzaga University Hospital, Department of Emergency Medicine
Orbassano, Torino, 10043
About this study
Official title: Focused Multiorgan Ultrasound in the Emergency Evaluation of 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.
Read more
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).
- Conditions
- Hypotension
- Keywords
- Emergency ultrasound, Focused ultrasound, Point-of-care ultrasound, Undifferentiated hypotension
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the ultrasound primary diagnosis and the clinical final diagnosis
Measured: Clinical judgment on the final diagnosis as deduced from all the data obtained after hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Volpicelli, San Luigi Gonzaga Hospital
- Investigators
- Giovanni Volpicelli, MD, Principal investigator, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572571
- Sponsor's protocol ID
- SLG-182/2011
- Acronym
- US-UHP
- Status last verified
- Dec 2013
- First submitted
- 4 Apr 2012
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19164614Jones 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. doi: 10.1097/01.ccm.0000133017.34137.82.
PubMed 15286547Rose 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. doi: 10.1053/ajem.2001.24481.
PubMed 11447518Copetti 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.
PubMed 22266231
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Multiorgan Ultrasound in the Emergency Evaluation of Undifferentiated Hypotension
- ClinicalTrials.gov ID
- NCT01572571
- Acronym / sponsor ID
- US-UHP / SLG-182/2011
- Conditions
- Hypotension
- Keywords
- Emergency ultrasound, Focused ultrasound, Point-of-care ultrasound, Undifferentiated hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to the Emergency Department with undifferentiated hypotension
Key inclusion criteria (7 listed)
- Arterial pressure <100 mm/Hg at presentation
- At least one of the following symptoms:
- Unresponsive
- Syncope
- Impaired mental status
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Background: PubMed 19164614Atkinson 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.
- Background: PubMed 15286547Jones 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. doi: 10.1097/01.ccm.0000133017.34137.82.
- Background: PubMed 11447518Rose 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. doi: 10.1053/ajem.2001.24481.
- Background: PubMed 22266231Copetti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Volpicelli, MD principal investigator
San Luigi Gonzaga Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by San Luigi Gonzaga Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572571, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.