- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03222778
Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery
26. marts 2020 opdateret af: Yonsei University
In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid resuscitation guided by reliable preload indices is of pivotal importance as only half of them are fluid responsive, and that empiric fluid administration actually leads to dismal prognosis.
In the continuum of being non-invasive, combinations of tissue Doppler-derived parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'), and LV stiffness (e'/a').
Although the left ventricular end-diastolic area (LVEDA) alone is not a valid predictor of fluid responsiveness, combining LVEDA with these indices would provide comprehensive information regarding the LV dimension, preload, and compliance as well as systolic function.
Also, it seems logical to assume that patients with low LVEDA and high e' velocity indicating preserved early diastolic relaxation or low e (early mitral inflow velocity) /e' ratio indicating normal LV filling pressure would more likely be fluid responsive.
Yet, these assumptions have not been tested before.
Moreover, these values can be reliably obtained regardless of the heart rhythm, except for a', and do not completely rely on heart-lung interaction as opposed to the dynamic indices.
Thus, the aim of this prospective trial is to investigate the role of LVEDA combined with e, e', a' or s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump coronary bypass surgery, in closed-chest conditions.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
66
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Seoul, Korea, Republikken, 120-752
- Department of Anesthesiology and Pain Medicine
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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
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
patients scheduled for off-pump coronary bypass surgery
Beskrivelse
Inclusion Criteria:
- the patients scheduled for off-pump coronary bypass surgery
- tha age ≥20 yrs old
- the patients who are willing to provide written informed consent
Exclusion Criteria:
heart rhythm other than sinus, L, septal and/or lateral wall motion abnormalities, and a
- New York Heart Association functional class ≥III
- LV ejection fraction <40%
- emergency operation
- the patients with preoperative septal and/or lateral wall motion abnormalities
- contraindications to transesophageal echocardiography or balanced 6% hydroxyethyl starch 130/0.4
- the patients with any valvular heart disease ≥moderate degree
- No communication possible due to a language barrier or deafness
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 |
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hypovolemia (fluid responsiveness)
The patients with fluid responsiveness (an increase in stroke volume index of ≥12%) after fluid challenge using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4
(Volulyte; Fresenius Kabi, Bad Homburg, Germany)
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NO hypovolemia (NO fluid responsiveness)
The patients without fluid responsiveness after fluid challenge using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4
(Volulyte; Fresenius Kabi, Bad Homburg, Germany)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Predictive ability of combined echocardiographic index consisting of LVEDA, e, e', s' or a'
Tidsramme: 15 to 20 min after anesthetic induction during closed chest condition
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Fluid challenge is performed once using 6 ml/kg of balanced 6% hydroxyethyl starch 130/0.4
(Volulyte; Fresenius Kabi, Bad Homburg, Germany) 15 to 20 min after anesthetic induction during closed chest condition.
Fluid responsiveness is defined as an increase in stroke volume index of ≥ 15%.
Assessment of echocardiographic variables [LVEDA, e, e', a' or s'] is performed before fluid challenge.
We assess the predictive ability of a combined echocardiographic preload index consisting of LVEDA, e, e', s' or a' on fluid responsiveness using the area under the Receiver Operating Characteristic (ROC) curve (AUROC).
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15 to 20 min after anesthetic induction during closed chest condition
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Comparison between the combine echocardiographic index and LVEDA alone, CVP, PCWP, RVEDV and PPV for the predictive ability on fluid responsiveness
Tidsramme: 15 to 20 min after anesthetic induction during closed chest condition
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CVP, PCWP, RVEDV and PPV are measured as well as echocardiographic variables [LVEDA, e, e', a' or s'] before fluid challenge.
We also assess the predictive ability of LVEDA alone, CVP, PCWP, RVEDV and PPV on fluid responsiveness using each AUROC, and compare the predictive power of the combined echocardiographic index on fluid responsiveness with those of the LVEDA alone, CVP, PCWP, RVEDV, and PPV.
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15 to 20 min after anesthetic induction during closed chest condition
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Samarbejdspartnere og efterforskere
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Sponsor
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. december 2017
Primær færdiggørelse (Faktiske)
6. marts 2020
Studieafslutning (Faktiske)
6. marts 2020
Datoer for studieregistrering
Først indsendt
9. juli 2017
Først indsendt, der opfyldte QC-kriterier
17. juli 2017
Først opslået (Faktiske)
19. juli 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 4-2017-0403
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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European Society of Intensive Care MedicineAfsluttet