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Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)

7 augustus 2014 bijgewerkt door: Michael Sander, Charite University, Berlin, Germany
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.

Studie Overzicht

Toestand

Onbekend

Conditie

Studietype

Observationeel

Inschrijving (Verwacht)

68

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Berlin, Duitsland, 10117
        • Werving
        • Charité Universitätsmedizin Berin
        • Onderonderzoeker:
          • Felix Balzer, MD
        • Contact:
        • Onderonderzoeker:
          • Sascha Treskatsch, MD
        • Onderonderzoeker:
          • Marit Habicher, MD
        • Onderonderzoeker:
          • Viktor Mezger, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Cardiac surgery at a university hospital

Beschrijving

Inclusion Criteria:

  • scheduled transcatheter aortic valve implantation
  • signed patient consent form
  • aged 18 or older by time of surgery
  • no participation in other clinical trials

Exclusion Criteria:

  • pregnant or breast-feeding women
  • emergency surgery

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Hemodynamic optimisation
No hemodynamic optimisation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Tijdsspanne: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Tijdsspanne: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Tijdsspanne: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
Tijdsspanne: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
Tijdsspanne: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Tijdsspanne: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Andere uitkomstmaten

Uitkomstmaat
Tijdsspanne
oxygen delivery (ml)
Tijdsspanne: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
image quality of echocardiography
Tijdsspanne: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of stay on ICU
Tijdsspanne: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Cumulative rate of infections
Tijdsspanne: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of delirium after surgery
Tijdsspanne: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
dosage of inotropic medication (mg/d)
Tijdsspanne: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
length of hospital stay
Tijdsspanne: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of stroke
Tijdsspanne: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Charite University, Berlin, Germany

Onderzoekers

  • Hoofdonderzoeker: Michael Sander, MD, Charite University, Berlin, Germany

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2014

Primaire voltooiing (Verwacht)

1 mei 2015

Studieregistratiedata

Eerst ingediend

20 mei 2014

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2014

Eerst geplaatst (Schatting)

5 juni 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

8 augustus 2014

Laatste update ingediend die voldeed aan QC-criteria

7 augustus 2014

Laatst geverifieerd

1 augustus 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • EA1/060/13

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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