Clinical trial NCT05613647: Concordance Study of Therapeutic Decision-making in Patients With Shock Based on Hemodynamic Monitoring
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Shock
Acute Circulatory Failure
Hemodynamic Monitoring
Keywords: hemodynamic monitoring
Concordance of decision
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-11-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in intensive care unit for shock with cardiac output monitoring by transpulmonary thermodilution and with hemodynamic instability

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intra-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
timeFrame: at inclusion
Secondary outcomes:
measure: Inter-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.
timeFrame: at inclusion
measure: Intra and inter expert concordance of therapeutic management according to PICCO device or without advance cardiac output monitoring.
timeFrame: at inclusion
measure: History and clinical situation
timeFrame: at inclusion
measure: Decision of volume expansion
timeFrame: at inclusion
measure: frequency of volume expansion, change in norepinephrine and dobutamine according to the method of cardiac output monitoring.
timeFrame: at inclusion
measure: the description of the expert population
timeFrame: at inclusion
measure: the concordance between experts and clinician management
timeFrame: at inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Pierre ASFAR, MD- PhD
role: PRINCIPAL_INVESTIGATOR
References: