Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)
7 augusti 2014 uppdaterad av: 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.
Studieöversikt
Status
Okänd
Betingelser
Studietyp
Observationell
Inskrivning (Förväntat)
68
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Berlin, Tyskland, 10117
- Rekrytering
- Charité Universitätsmedizin Berin
-
Underutredare:
- Felix Balzer, MD
-
Kontakt:
- Michael Sander, MD
- Telefonnummer: +4930450531052
- E-post: michael.sander@charite.de
-
Underutredare:
- Sascha Treskatsch, MD
-
Underutredare:
- Marit Habicher, MD
-
Underutredare:
- Viktor Mezger, MD
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Cardiac surgery at a university hospital
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Hemodynamic optimisation
|
|
No hemodynamic optimisation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 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
Tidsram: 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]
Tidsram: 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
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
oxygen delivery (ml)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Michael Sander, MD, Charite University, Berlin, Germany
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2014
Primärt slutförande (Förväntat)
1 maj 2015
Studieregistreringsdatum
Först inskickad
20 maj 2014
Först inskickad som uppfyllde QC-kriterierna
2 juni 2014
Första postat (Uppskatta)
5 juni 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 augusti 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 augusti 2014
Senast verifierad
1 augusti 2014
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- EA1/060/13
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .