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Evaluation of the Argos System to Estimate Cardiac Output

20. juli 2026 opdateret af: Christopher Lai, Bicetre Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

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Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: 1 hour (before and after intervention)
1 hour (before and after intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Accuracy of the Argos system
Tidsramme: 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
1 hour (before and after intervention)
Precision of the Argos system
Tidsramme: 1 hour (before and after intervention)
To evaluate the precision and least significant change of cardiac output provided by the Argos system
1 hour (before and after intervention)

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. januar 2027

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

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Kliniske forsøg med Stød

Kliniske forsøg med Fluid bolus

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