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Time Course Evolution of Cardiac Output (TCCO)

Time Course Evolution of Cardiac Output in Critically Ill Patients After a Fluid Expansion

Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown.

This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion.

The objectives are:

  1. to identify patterns of fluid responsiveness
  2. to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
  3. to compare patients' characteristics between patterns

Patients with acute circulatory failure will be recruited as soon as a fluid expansion will be decided by the physician in charge and the effects of fluid expansion on hemodynamic indices (cardiac output, arterial pressure) will be continuously recorded through a transpulmonary thermodilution device over a 2-hours period.

No changes in ventilatory settings nor vasopressors or sedatives will be allowed during the study.

Patients will be categorized into patterns according to the changes in cardiac output after fluid expansion and their characteristics will be compared.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The study will be conducted in four medico-surgical ICUs in France between April 2016 and April 2018.

Since fluid challenge and invasive monitoring by thermodilution device is standard of care for septic shock management, the institutional review board waived patient consent. All patients and/or their next of kind will receive written information.

Eligible patients will have to present an acute circulatory failure for whom the physician in charge will decide to start a fluid expansion.

Hemodynamic variables will be obtained through transpulmonary thermodilution and pulse contour analysis (PICCO2 device, Pulsion Germany).

Fluid expansion will consist in the infusion of 500 ml of saline through a central venous catheter in a standardized 10-minutes period. The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.

Fluid responsiveness will be defined by an increase in cardiac output over 15-per-cent from baseline (before fluid expansion).

Study design:

At time of decision to make the fluid expansion, a calibration of the PICCO2 device will be performed and a first set of hemodynamic measurements will be collected (cardiac output, cardiac function index, extravascular lung water, permeability vascular pulmonary index, global end diastolic volume, arterial pressure, heart rate).

Then, fluid expansion will be administrated in less than 10 minutes. From the start of fluid expansion to the end of the two-hours period ot time, pulse contour cardiac output and arterial pressure will be continuously recorded.

During the whole two hours period, no change in vasopressor dosage nor mechanical ventilation settings will be allowed.

In case of hemodynamic instability, defined by a mean arterial pressure under 65mmHg, a new fluid expansion could be realized. In this last case, the protocol will start again from the beginning.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

58

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

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Critically ill patients admitted in the intensive care unit receiving mechanical ventilation and presenting an acute circulatory failure.

Beskrivelse

Inclusion Criteria:

  • acute circulatory failure (infusion of norepinephrine)
  • invasive mechanical ventilation through an endotracheal tube
  • decision of fluid expansion

Non inclusion Criteria:

  • extracorporeal membranous oxygenation (ECMO)
  • active bleeding
  • continuous renal replacement therapy with weight loss
  • administration of diuretics within the past six hours
  • decision of therapeutic limitation,
  • age under eighteen years

Exclusion criteria:

  • hemodynamic instability after fluid expansion (mean arterial pressure < 65mmHg)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients
The patients will receive a 500 ml fluid expansion over a standardized 10 minutes period
The fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cardiac output during fluid expansion
Tidsramme: 10 minutes
Difference between maximal cardiac output during fluid expansion and baseline
10 minutes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cardiac output after fluid expansion
Tidsramme: 2 hours
Change in cardiac output after fluid expansion
2 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Martin Dres, MD, PhD, APHP

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

15. april 2016

Primær færdiggørelse (Faktiske)

15. maj 2018

Studieafslutning (Faktiske)

31. maj 2018

Datoer for studieregistrering

Først indsendt

2. oktober 2018

Først indsendt, der opfyldte QC-kriterier

2. oktober 2018

Først opslået (Faktiske)

3. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ADOREPS

Plan for individuelle deltagerdata (IPD)

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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