Evaluation of the Argos System to Estimate Cardiac Output

NCT07724262 | Recruiting

• 2 other identifiers: Argos studyCE-SRLF 24-100
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock

Keywords

hemodynamic monitoring; vasopressor; fluids; cardiac output

Outcome Measures

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.

  1 hour (before and after intervention)

Secondary Outcomes (2)

• Accuracy of the Argos system

  1 hour (before and after intervention)

• Precision of the Argos system

  1 hour (before and after intervention)

Study Arms (1)

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

Drug: Fluid bolus; Drug: Norepinephrine

Interventions

Fluid bolus DRUG

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

patients with shock

Norepinephrine DRUG

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

patients with shock

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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

Bicêtre Hospital

Le Kremlin-Bicêtre, France

RECRUITING

MeSH Terms

Conditions

Shock

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Christopher Lai, MD, PhD

CONTACT

12633816521; christopher.lai@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

FR (1)