ShockPICC-ECHONCT05613647
Concordance Study of Therapeutic Decision-making in Patients With Shock Based on Hemodynamic Monitoring
An observational study of Shock and Acute Circulatory Failure, run by University Hospital, Angers at 1 site in France.
Trial summary
Shock is a serious complication corresponding to acute circulatory failure resulting in multiorgan failure and death. In order to improve cellular oxygen utilization, several therapies can be used. To select one of them, the monitoring of cardiac output is helpful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Acute Circulatory Failure, Hemodynamic Monitoring
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2022to Jan 2026
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient in intensive care unit for shock with cardiac output monitoring by transpulmonary thermodilution and with hemodynamic instability
Who may be able to join
- adult patient, hospitalized in the Intensive Care Medicine, CHU of Angers;
- patient requiring a hemodynamic evaluation because of an acute circulatory insufficiency defined by : arterial hypotension requiring vasopressor amines, with clinical signs (mottling, encephalopathy, oliguria > 2h) and/or biological signs (pH <7.38; lactate > 2 mmol/L) of tissue hypoperfusion;
- patient monitored by transpulmonary thermodilution with pulse wave contour measurement (PiCCO) as part of routine care.
Who cannot join
- patient with acute pulmonary heart on TTE (defined as a LV-to-VG ratio > 0.6 associated with a paradoxical interventricular septum);
- patient objecting to participation in the research;
- a relative who has received the information, if the patient's condition does not allow it, and who objects to the participation of his or her relative in the research;
- persons protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance Study of Therapeutic Decision-making in Patients With Acute Circulatory Failure Between Cardiac Output Monitoring by Transthoracic Echocardiography and by Transpulmonary Thermodilution : PICC-ECHO Study
Shock is a serious complication corresponding to acute circulatory failure resulting in multiorgan failure and death. In order to improve cellular oxygen utilization, several therapies can be used. To select one of them, the monitoring of cardiac output is helpful. However, there are several methods used in current practice in intensive care for evaluating hemodynamic.
Currently, in patients with acute circulatory failure, no study has compared the concordance of therapeutic decision-making based on transpulmonary thermodilution or transthoracic echocardiography.
Read more
The objective of the PICC-ECHO study is thus to assess the concordance of therapeutic decision-making by several experts, based on data from transpulmonary thermodilution or transthoracic echocardiography.
Indeed, the investigators hypothesize that performing hemodynamic monitoring based on transpulmonary thermodilution or transthoracic echocardiography does not lead to the same therapeutic management in patients in shock.
Read the detailed description
PICC-ECHO is a monocentric, prospective, non interventional, exploratory study to assess the concordance of therapeutic decision-making between two strategies used in current practice, transthoracic echocardiography and transpulmonary thermodilution, in patients with acute circulatory failure.
Each patient in shock with cardiac output monitoring by transpulmonary thermodilution is identified and then eligible for inclusion.
After inclusion, measurements of cardiac output with PICCO device and transthoracic echocardiography will be performed before and after a passive leg raising test and a respiratory occlusion test if patient are under invasive mechanical ventilation.
These assessments will be conducted by two different investigators, to be sure that data by transthoracic echocardiography will not be influenced by the measurements collected by the analysis of the transpulmonary thermodilution.
Clinical, biological, echocardiographic and transpulmonary thermodilution data will be then collected on a database.
The therapeutic management of the clinicianresponsible for the patient will also be collected.
The database will be used as support for the drafting of three medical observations for each patient on an electronic CRF : one with data from transpulmonary thermodilution, one with data from transthoracic echocardiography, and one with only clinico-biological parameters (without advanced monitoring).
At the end, 45 different files will be compiled and submitted to different intensive care physicians (between 10 and 20) working outside the investigative team (" experts ").
In order to avoid any recognition between the three versions of a same patient, the investigators will undergo a semantic variation and the mailings will be done in three distinct groups corresponding to the three methods separated by a few weeks.
For each clinical case, experts will have to choose about the following choices: volume expansion, increase norepinephrine, introduction or increase dobutamine, abstention with continuation of current therapy.
Vital status of the patient as well as the use of supportive care (mechanical ventilation, renal-replacement therapy, vasoactive drug, other assistance) and their duration will be collected at day n°28.
For each case, the investigators will evaluate the concordance of decision of each expert, depending on whether the informations was collected by PICCO device, by echocardiography or without invasive monitoring.
- Conditions
- Shock, Acute Circulatory Failure, Hemodynamic Monitoring
- Keywords
- hemodynamic monitoring, Concordance of decision
- Medical subject headings
- Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
the concordance of hypothetical therapeutic decision-making done a posteriori by experts in patients with acute circulatory failure between cardiac output monitoring by transthoracic echocardiography or by transpulmonary thermodilution.
Measured: at inclusion
Secondary outcomes (7)
Inter-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
the inter-expert concordance of therapeutic management according to data from transpulmonary thermodilution or transthoracic echocardiography.
Measured: at inclusion
Intra and inter expert concordance of therapeutic management according to PICCO device or without advance cardiac output monitoring.
the intra-expert and inter-expert concordance of theoretical therapeutic management according to data provided by PICCO device or without cardiac output monitoring
Measured: at inclusion
History and clinical situation
the difference in history and clinical situation in patients for whom theoretical therapeutic management is discordant or not according to the different methods: PICCO device vs echocardiography; PICCO vs no hemodynamic monitoring; echocardiography vs no hemodynamic monitoring
Measured: at inclusion
Decision of volume expansion
the intra-expert and inter-expert concordance of the decision of volume expansion according to data from the different methods: PICCO vs echocardiography, PICCO vs no hemodynamic monitoring, echocardiography vs no hemodynamic monitoring
Measured: at inclusion
frequency of volume expansion, change in norepinephrine and dobutamine according to the method of cardiac output monitoring.
the frequency of use of volume expansion, vasopressor support and inotropic support (dobutamine) according to the method of cardiac output monitoring: PICCO vs echocardiography, PICCO vs no hemodynamic monitoring, echocardiography vs no hemodynamic monitoring
Measured: at inclusion
the description of the expert population
Description of the expert population (seniority in the intensive care unit, place of practice : hospital or university hospital, number of beds in the intensive care unit in which the expert works, which haemodynamic monitoring tool is used in current practice by the expert.
Measured: at inclusion
the concordance between experts and clinician management
Concordance of decision between expert and clinician management
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start13 Dec 2022
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
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 University Hospital, AngersThe 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
- 15 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ASFAR, MD- PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613647
- Sponsor's protocol ID
- 2022-A02017-36
- Acronym
- PICC-ECHO
- Status last verified
- Jun 2025
- First submitted
- 30 Oct 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Study of Therapeutic Decision-making in Patients With Acute Circulatory Failure Between Cardiac Output Monitoring by Transthoracic Echocardiography and by Transpulmonary Thermodilution : PICC-ECHO Study
- ClinicalTrials.gov ID
- NCT05613647
- Acronym / sponsor ID
- PICC-ECHO / 2022-A02017-36
- Conditions
- Shock, Acute Circulatory Failure, Hemodynamic Monitoring
- Keywords
- hemodynamic monitoring, Concordance of decision
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Nov 2022 (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.
Shock is a serious complication corresponding to acute circulatory failure resulting in multiorgan failure and death. In order to improve cellular oxygen utilization, several therapies can be used. To select one of them, the monitoring of cardiac output is helpful. However, there are several methods used in current practice in intensive care for evaluating hemodynamic.
Currently, in patients with acute circulatory failure, no study has compared the concordance of therapeutic decision-making based on transpulmonary thermodilution or transthoracic echocardiography.
The objective of the PICC-ECHO study is thus to assess the concordance of therapeutic decision-making by several experts, based on data from transpulmonary thermodilution or transthoracic echocardiography.
Indeed, the investigators hypothesize that performing hemodynamic monitoring based on transpulmonary thermodilution or transthoracic echocardiography does not lead to the same therapeutic management in patients in shock.
Detailed description
PICC-ECHO is a monocentric, prospective, non interventional, exploratory study to assess the concordance of therapeutic decision-making between two strategies used in current practice, transthoracic echocardiography and transpulmonary thermodilution, in patients with acute circulatory failure.
Each patient in shock with cardiac output monitoring by transpulmonary thermodilution is identified and then eligible for inclusion.
After inclusion, measurements of cardiac output with PICCO device and transthoracic echocardiography will be performed before and after a passive leg raising test and a respiratory occlusion test if patient are under invasive mechanical ventilation.
These assessments will be conducted by two different investigators, to be sure that data by transthoracic echocardiography will not be influenced by the measurements collected by the analysis of the transpulmonary thermodilution.
Clinical, biological, echocardiographic and transpulmonary thermodilution data will be then collected on a database.
The therapeutic management of the clinicianresponsible for the patient will also be collected.
The database will be used as support for the drafting of three medical observations for each patient on an electronic CRF : one with data from transpulmonary thermodilution, one with data from transthoracic echocardiography, and one with only clinico-biological parameters (without advanced monitoring).
At the end, 45 different files will be compiled and submitted to different intensive care physicians (between 10 and 20) working outside the investigative team (" experts ").
In order to avoid any recognition between the three versions of a same patient, the investigators will undergo a semantic variation and the mailings will be done in three distinct groups corresponding to the three methods separated by a few weeks.
For each clinical case, experts will have to choose about the following choices: volume expansion, increase norepinephrine, introduction or increase dobutamine, abstention with continuation of current therapy.
Vital status of the patient as well as the use of supportive care (mechanical ventilation, renal-replacement therapy, vasoactive drug, other assistance) and their duration will be collected at day n°28.
For each case, the investigators will evaluate the concordance of decision of each expert, depending on whether the informations was collected by PICCO device, by echocardiography or without invasive monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient in intensive care unit for shock with cardiac output monitoring by transpulmonary thermodilution and with hemodynamic instability
Key inclusion criteria (3 listed)
- adult patient, hospitalized in the Intensive Care Medicine, CHU of Angers;
- patient requiring a hemodynamic evaluation because of an acute circulatory insufficiency defined by : arterial hypotension requiring vasopressor amines, with clinical signs (mottling, encephalopathy, oliguria > 2h) and/or biological signs (pH <7.38; lactate > 2 mmol/L) of tissue hypoperfusion;
- patient monitored by transpulmonary thermodilution with pulse wave contour measurement (PiCCO) as part of routine care.
Key exclusion criteria (4 listed)
- patient with acute pulmonary heart on TTE (defined as a LV-to-VG ratio > 0.6 associated with a paradoxical interventricular septum);
- patient objecting to participation in the research;
- a relative who has received the information, if the patient's condition does not allow it, and who objects to the participation of his or her relative in the research;
- persons protected by law.
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
Intra-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
Time frame: at inclusion
the concordance of hypothetical therapeutic decision-making done a posteriori by experts in patients with acute circulatory failure between cardiac output monitoring by transthoracic echocardiography or by transpulmonary thermodilution.
7 secondary outcomes
Inter-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
Time frame: at inclusion
Intra and inter expert concordance of therapeutic management according to PICCO device or without advance cardiac output monitoring.
Time frame: at inclusion
History and clinical situation
Time frame: at inclusion
Decision of volume expansion
Time frame: at inclusion
frequency of volume expansion, change in norepinephrine and dobutamine according to the method of cardiac output monitoring.
Time frame: at inclusion
the description of the expert population
Time frame: at inclusion
the concordance between experts and clinician management
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
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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.
Pierre ASFAR, MD- PhD principal investigator
University Hospital, Angers
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 and Acute Circulatory Failure, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intra-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring. (time frame: at inclusion). 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 15 Jun 2025.