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

NCT05613647 | Active Not Recruiting DMC

• 1 other identifier: 2022-A02017-36
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Acute Circulatory Failure; Hemodynamic Monitoring

Keywords

hemodynamic monitoring; Concordance of decision

Outcome Measures

Primary Outcomes (1)

• 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.

  at inclusion

Secondary Outcomes (7)

• Inter-expert concordance of therapeutic management according to PICCO device or echocardiography monitoring.

  at inclusion

• Intra and inter expert concordance of therapeutic management according to PICCO device or without advance cardiac output monitoring.

  at inclusion

• History and clinical situation

  at inclusion

• Decision of volume expansion

  at inclusion

• frequency of volume expansion, change in norepinephrine and dobutamine according to the method of cardiac output monitoring.

  at inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre ASFAR, MD- PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: December 13, 2022
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

FR (1)