Health TrialsbyHealthPanel

Evaluation of the Argos System to Estimate Cardiac Output

ConditionShock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBicetre Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: patients with shock2 interventions

Trial outcomes

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

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)
2

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bicetre Hospital

Lead sponsor

Source ClinicalTrials.gov
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