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Evaluation of the Argos System to Estimate Cardiac Output

Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07724262
Enrollment
120
Registered
2026-07-24
Start date
2026-02-01
Completion date
2027-01-31
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

Keywords

hemodynamic monitoring, vasopressor, fluids, cardiac output

Brief summary

The goal of this observational study is to evaluate the reliability of the Argos system to track changes in cardiac output in critically ill patients. The main question it aims to answer is: Does cardiac output changes induced by fluid administration or changes in norepinephrine dosage can be tracked by the Argos system, compared to transpulmonary thermodilution device.

Detailed description

In patients with acute circulatory failure, hemodynamic monitoring including cardiac index (CI) assessment is recommended for most severe patients. Transpulmonary thermodilution (TPTD) is one of the methods that are recommended for this purpose, in particular because it is considered as reliable in this type of patients. The PiCCO2 system (Pulsion Medical Systems, Getinge, Feldkirchen, Germany) relies on TPTD method and associate two methods to measure CI. On the one hand, TPTD is considered as one of the gold standards for CI evaluation (CITPTD). On the other hand, pulse contour analysis calculates stroke volume from the waveform of the systolic part of the arterial pressure curve (CIpwa). The way this estimation is performed and it is regularly re-evaluated differs among the devices that are available on the market. This estimation of CIpwa is calibrated when TPTD is performed. Thus, it allows a real-time pulse contour derived CI assessment, which is very precise. However, TPTD system are considered invasive, expensive and are not available in all settings. The Argos monitor (Retia Medical, Valhalla, USA) uses the so-called multi-beat analysis (MBA) to estimate CI after analyzing the arterial pressure waveform over periods of multiple heartbeats (up to 20) and scaling CI estimations to biometric data. The algorithm estimates the theoretical central arterial blood pressure waveform using MBA, minimizing and avoiding the cofounding effect of the wave reflection phenomena. Based on this central arterial blood pressure waveform and biometric patient data, the system estimates cardiac output. The Argos monitor has a second advantage. It simply connects to the analogue output of the blood pressure signal from a compatible multi-parameter monitor and needs no additional specific pressure sensor. During cardiac surgery, the Argos monitor showed reasonable agreement and trending ability compared to the pulmonary artery catheter. However, in patients after cardiac surgery, including those with low cardiac output and arrhythmia, CI estimated by the device was not interchangeable with the continuous thermodilution method via a PAC. The primary objective of the study is to evaluate the reliability of the Argos system to track changes of CI induced by changes in norepinephrine or fluid administration, compared to CITPTD in critically ill patients.

Interventions

Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%)

DRUGNorepinephrine

brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves

Sponsors

Bicetre Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years old * Hospitalisation in intensive care * Haemodynamic monitoring with transpulmonary thermodilution already in place * Hemodynamic intervention deemed necessary by the clinician in charge of the patient * Administration of a fluid bolus * Change in norepinephrine dosage or performance of a vasopressor test

Exclusion criteria

* Pregnancy * Other therapeutic modification during volume expansion or the vasopressor test * Refusal to participate by relatives of the patient or the patient himself or herself * Non availability of investigators

Design outcomes

Primary

MeasureTime frame
To compare the changes in cardiac output provided by the Argos system induced by changes in norepinephrine or fluid bolus, compared to cardiac output provided by the transpulmonary thermodilution device in critically ill patients.1 hour (before and after intervention)

Secondary

MeasureTime frameDescription
Accuracy of the Argos system1 hour (before and after intervention)To evaluate the accuracy of the Argos system to measure absolute values of cardiac output compared to transpulmonary thermodilution
Precision of the Argos system1 hour (before and after intervention)To evaluate the precision and least significant change of cardiac output provided by the Argos system

Countries

France

Contacts

CONTACTChristopher Lai, MD, PhD
christopher.lai@aphp.fr12633816521

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026