Concordance Study of Therapeutic Decision-making in Patients With Shock Based on Hemodynamic Monitoring

NCT ID: NCT05613647

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2026-01-31

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.

Conditions

Shock; Acute Circulatory Failure; Hemodynamic Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre ASFAR, MD- PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

CHU Angers

Angers, , France

Countries

France

Other Identifiers

2022-A02017-36

Identifier Type: -

Identifier Source: org_study_id