ShockNCT07724262
Evaluation of the Argos System to Estimate Cardiac Output
An observational study of Shock, run by Bicetre Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Fluid bolus and Norepinephrine
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2026to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Bicêtre Hospital
Le Kremlin-Bicêtre
Christopher Lai, 2633816521, christopher.lai@aphp.fr
About this study
Official title: Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients
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.
Read the 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.
- Conditions
- Shock
- Being tested
- Fluid bolus, Norepinephrine
- Keywords
- hemodynamic monitoring, vasopressor, fluids, cardiac output
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid bolusDrug
Giving a fluid bolus of 500mL of normal saline (NaCl 0.9%)
NorepinephrineDrug
brief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves
| Study group | Role | What they receive |
|---|---|---|
| patients with shock | 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 Receives: Drug: Fluid bolus; Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour (before and after intervention)
Secondary outcomes (2)
Accuracy of the Argos system
To evaluate the accuracy of the Argos system to measure absolute values of cardiac output compared to transpulmonary thermodilution
Measured: 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
Measured: 1 hour (before and after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Lai, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724262
- Sponsor's protocol ID
- Argos study
- Other IDs
- CE-SRLF 24-100
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Argos System to Estimate Cardiac Output in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07724262
- Acronym / sponsor ID
- Argos study
- Conditions
- Shock
- Keywords
- hemodynamic monitoring, vasopressor, fluids, cardiac output
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with shock | – | Drug: Fluid bolus, Drug: NorepinephrinePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid bolusGiving a fluid bolus of 500mL of normal saline (NaCl 0.9%) | Drug | patients with shock |
| Norepinephrinebrief, transient increase in norepinephrine to achieve a 15mmHg increase in mean arterial pressure and evaluates if tissue perfusion improves | Drug | patients with shock |
Primary outcome
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)
2 secondary outcomes
Accuracy of the Argos system
Time frame: 1 hour (before and after intervention)
Precision of the Argos system
Time frame: 1 hour (before and after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Bicetre Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Lai, MD, PhD (12633816521, christopher.lai@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.