The Impact of Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients (ECHOCARD)
19. november 2018 oppdatert av: Asta Maculiene, Lithuanian University of Health Sciences
The Impact of Extended Hemodynamic Monitoring by Focused Transthoracic Echocardiography in Urgent Abdominal Surgery for Septic Patients
The aim of the study is to identify the diagnostic value of the focused assessed echocardiography in septic patients undergoing urgent abdominal surgery due to peritonitis.
The investigators expect that the incidence of hemodynamic instability will be reduced and the survival of the patients will be improved.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Often sepsis remains undiagnosed at the very beginning because of the concentration to the surgical pathology in perioperative period. This results in unacceptably high mortality. The investigators hypothesize that extended hemodynamic monitoring by focused transthoracic echocardiography will personalize early fluid resuscitation which will improve patient's outcome.
The goals of the investigators study are:
- To conduct two-group randomized controlled clinical trial to compare patient management based on standard monitoring and extended hemodynamic monitoring by focused transthoracic echocardiography in patients undergoing urgent abdominal surgery due to peritonitis.
- To demonstrate that patient management based on extended hemodynamic monitoring by focused echocardiography results in improved survival, reduced incidence of hemodynamic instability during perioperative period.
- To compare an amount of administrated of intravenous fluids in both groups.
The investigators hypothesize that focused echocardiography monitoring will result in more administrated intravenous fluids during perioperative period.
Studietype
Intervensjonell
Registrering (Faktiske)
131
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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A. Mickeviciaus Street 9
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Kaunas, A. Mickeviciaus Street 9, Litauen, LT-44307
- Lithuanian university of health sciencies
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age more than 18 years old.
- Patients undergoing urgent abdominal surgery due to diffuse peritonitis.
- SOFA score >2.
- Patients who sign an agreement to participate in the study.
Exclusion Criteria:
- Younger than 18 years old.
- Known pregnancy.
- Unconscious patients or those who do not agree to participate in the study.
- Contraindication to central venous or arterial catheterization.
- Patients who were already treated in ICU because of sepsis or septic shock before this surgery.
- Known chronic renal failure.
- Re-laparotomy.
- Peritonitis due to acute mesenteric ischaemia, thrombosis or trauma.
- Dying patients.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Non-echo group
Patients get the standard monitoring and treatment based on Good medical practice.
Extended monitoring by focused echocardiography is not applied for this group.
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Eksperimentell: Focussed echocardiography group
The extended cardiac monitoring by focused assessed transthoracic echocardiography is applied.
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Focused assessed transthoracic echocardiography is non-invasive, painless procedure.
The transducer is placed on the chest at certain locations and angles to get the required information on patient's condition.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Inpatient mortality in both treatment arms.
Tidsramme: 30 days intra-hospital mortality
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Comparison of 30 days intra-hospital mortality in both arms.
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30 days intra-hospital mortality
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of incidence of severe hypotension MAP <65 mmHg after anaesthesia induction in both arms.
Tidsramme: 1-5 minutes after anaesthesia induction.
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To evaluate the incidence of severe hypotension after anesthesia induction (1 - 5 minutes after induction) in both groups.
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1-5 minutes after anaesthesia induction.
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Comparison of fluid management in both arms (from hospitalisation to the surgery, during the surgery, after the surgery up to 24 hours).
Tidsramme: up to 24 hours
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Comparison of tow fluids management strategies.
Usual monitoring group - fluid management based on fluid responsiveness based by clinical sings.
FATE group - fluid management based on focused transthoracic echocardiography data.
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up to 24 hours
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Comparison of septic shock incidence in both arms.
Tidsramme: up to 30 days
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To compare the manifestation of septic shock (hemodynamics instability not responding to fluid administration, which requires norepinephrine infusion to maintain MAP ≥ 65 mmHg);
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up to 30 days
|
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Number of ICU-Free days.
Tidsramme: up to 30 days
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To compare ICU free days in both groups.
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up to 30 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studiestol: Andrius Macas, profesor, Lithuanian university of health sciencies
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2016
Primær fullføring (Faktiske)
1. januar 2017
Studiet fullført (Faktiske)
1. februar 2018
Datoer for studieregistrering
Først innsendt
25. juli 2016
Først innsendt som oppfylte QC-kriteriene
26. juli 2016
Først lagt ut (Anslag)
27. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. november 2018
Sist bekreftet
1. november 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MIP051/2015
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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