Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)
7 août 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Type d'étude
Observationnel
Inscription (Anticipé)
68
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 10117
- Recrutement
- Charité Universitätsmedizin Berin
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Sous-enquêteur:
- Felix Balzer, MD
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Contact:
- Michael Sander, MD
- Numéro de téléphone: +4930450531052
- E-mail: michael.sander@charite.de
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Sous-enquêteur:
- Sascha Treskatsch, MD
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Sous-enquêteur:
- Marit Habicher, MD
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Sous-enquêteur:
- Viktor Mezger, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Cardiac surgery at a university hospital
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Hemodynamic optimisation
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No hemodynamic optimisation
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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
Délai: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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
Délai: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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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
Délai: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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
Délai: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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]
Délai: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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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
Délai: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Autres mesures de résultats
Mesure des résultats |
Délai |
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oxygen delivery (ml)
Délai: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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image quality of echocardiography
Délai: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Length of stay on ICU
Délai: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Cumulative rate of infections
Délai: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of delirium after surgery
Délai: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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dosage of inotropic medication (mg/d)
Délai: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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length of hospital stay
Délai: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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incidence of stroke
Délai: after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Michael Sander, MD, Charite University, Berlin, Germany
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2014
Achèvement primaire (Anticipé)
1 mai 2015
Dates d'inscription aux études
Première soumission
20 mai 2014
Première soumission répondant aux critères de contrôle qualité
2 juin 2014
Première publication (Estimation)
5 juin 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 août 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 août 2014
Dernière vérification
1 août 2014
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- EA1/060/13
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