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NCT Number: NCT07724262

Evaluation of the Argos System to Estimate Cardiac Output

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bicêtre Hospital

Le Kremlin-Bicêtre, France

Location status: Recruiting

Location contact

Christopher Lai

CONTACT

[email protected]

2633816521

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid bolus

Drug

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

norepinephrine

Drug

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

Primary outcomes

  1. 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.

    Time frame: 1 hour (before and after intervention)

Secondary outcomes

  1. Accuracy of the Argos system

    Time frame: 1 hour (before and after intervention)

    To evaluate the accuracy of the Argos system to measure absolute values of cardiac output compared to transpulmonary thermodilution

  2. Precision of the Argos system

    Time frame: 1 hour (before and after intervention)

    To evaluate the precision and least significant change of cardiac output provided by the Argos system

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Lai, MD, PhD

CONTACT

[email protected]

12633816521

Sponsors and collaborators

Lead sponsor

Bicetre Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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