Shock3DICUNCT03270319
Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
An observational study of Shock, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to 31 Aug 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult intensive care patients treated in our intensive care unit with current hemodynamic unstable condition.
Who may be able to join
- advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place
- patient intubated or tracheostomy in place
- clinical indication for performing an echocardiography
- ongoing sedation requirement
Who cannot join
- Heart rhythm other than sinus rhythm or paced atrial rhythm
- Known allergy to sulphur-hexafluoride (SonoVue©)
- Artificial heart valves in place
- Any form of mechanical cardiac assist
- contraindication to performing a transesophageal echocardiography
- presence of significant cardiac valve regurgitation
- presence of an intracardiac shunt
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.
Read the detailed description
Prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter).
Critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included.
While performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured.
In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography.
The acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. We will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.
- Conditions
- Shock
- Keywords
- Measurement of cardiac output
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU patient | Critically ill patients in our adult intensive care unit with the following characteristics: * advanced hemodynamic monitoring in place including pulmonary artery catheter and arterial catheter * intubated or tracheostomy in place * echocardiography requested by the treating physician * intervention of interest: hemodynamic assessment done by echocardiography and thermodilution (pulmonary artery catheter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Feasibility of right ventricular pressure volume loops
Off-line analysis of pressure time curve for right ventricle using data from pulmonary artery catheter and volume time curve from echocardiographic data. Assessment of feasibility to combine these two curves to a pressure volume loop.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study startMay 2016
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Study team members moved away
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Bloch, MD, Principal investigator, Department of intensive care medicine, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270319
- Sponsor's protocol ID
- 16032016
- Acronym
- 3DICU
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2016
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Dimensional Echocardiography in Critical Care Medicine
- ClinicalTrials.gov ID
- NCT03270319
- Acronym / sponsor ID
- 3DICU / 16032016
- Conditions
- Shock
- Keywords
- Measurement of cardiac output
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study team members moved away
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 1 Sep 2017 (actual)
- 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.
Comparison of volumetric measurements obtained by three dimensional echocardiography with measurements obtained by thermodilution using a pulmonary artery catheter in the intensive care unit.
Detailed description
Prospective, observational study evaluating three dimensional echocardiography for measuring hemodynamic variables versus the current gold standard (pulmonary artery catheter).
Critically ill patients with a severly compromised circulation due to a shock state with an advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will be included.
While performing an echocardiography study stroke volume measurements using the bolus method for thermodilution will concomittantly be measured.
In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the image quality has improved we will repeat the stroke volume measurements with the bolus thermodilution method while performing the echocardiography.
The acquired echocardiography loops will then be analysed and measured offline once deferred consent has been obtained. We will then compare the echocardiographic measurements with the measurement obtained by the pulmonary artery catheter (bolus method) - since this is the current reference method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patient | – | –Critically ill patients in our adult intensive care unit with the following characteristics: * advanced hemodynamic monitoring in place including pulmonary artery catheter and arterial catheter * intubated or tracheostomy in place * echocardiography requested by the treating physician * intervention of interest: hemodynamic assessment done by echocardiography and thermodilution (pulmonary artery catheter) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care patients treated in our intensive care unit with current hemodynamic unstable condition.
Key inclusion criteria (4 listed)
- advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter in place
- patient intubated or tracheostomy in place
- clinical indication for performing an echocardiography
- ongoing sedation requirement
Key exclusion criteria (7 listed)
- Heart rhythm other than sinus rhythm or paced atrial rhythm
- Known allergy to sulphur-hexafluoride (SonoVue©)
- Artificial heart valves in place
- Any form of mechanical cardiac assist
- contraindication to performing a transesophageal echocardiography
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
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
Time frame: through study completion, an average of 1 year
The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.
1 secondary outcome
Feasibility of right ventricular pressure volume loops
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Study team members moved away). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Andreas Bloch, MD principal investigator
Department of intensive care medicine, Luzerner Kantonsspital
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 Shock, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Oct 2024. 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 Switzerland. 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 was stopped early (reason given: Study team members moved away). Results are not available in the source record.
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?
Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2024.