An observational study in Shock, sponsored by Bicetre Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Bicetre Hospital · Observational
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.
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.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with shock defined by one sign of hypoperfusion:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Hemodynamic intervention deemed necessary by the clinician in charge of the patient
Exclusion Criteria:
Patients with shock defined by one sign of hypoperfusion: * systolic arterial pressure \<90mmHg * mean arterial pressure \<65mmHg * prolonged capillary refill time \>3 sec * mottling score \> 2 * urine output \< 0.1 mL/kg/h
Drug: Fluid bolus · Drug: Norepinephrine
Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%)
brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves
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)
Accuracy of the Argos system
To evaluate the accuracy of the Argos system to measure absolute values of cardiac output compared to transpulmonary thermodilution
Time frame: 1 hour (before and after intervention)
Precision of the Argos system
To evaluate the precision and least significant change of cardiac output provided by the Argos system
Time frame: 1 hour (before and after intervention)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 10 months is below that.
Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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