|- candidate number||6580|
|- NTR Number||NTR2072|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-okt-2009|
|- Secondary IDs||M09-035 METC Noord Holland|
|- Public Title||Comparison of heart minute volume measured with the standard method (pulmonalis catheter) with a new method using the arterial wave form in groin or at the wrist in serious sick patients in the intensive care.
|- Scientific Title||Cardiac output measured by arterial pressure waveform analysis without manual calibration compared with thermodilution in critical ill patients.
Third generation waveform analysis performance in sepsic shock.|
|- hypothesis||The aim of the study is to determine whether cardiac output measurements obtained using APCO are comparable with those obtained using intermitted thermodilution cardiac output in critical ill patients.|
|- Healt Condition(s) or Problem(s) studied||Septic shock , Dynamic hemodynamic profiles|
|- Inclusion criteria||1. Sinus Rhythm; |
2. Septic Shock;
3. Inotropic support including Noradrenalin;
4. PA Catheter;
5. Informed consent.
|- Exclusion criteria||1. Non sinus rhythm;|
2. No informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||9-jan-2009|
|- planned closingdate||9-jan-2010|
|- Target number of participants||15|
|- Primary outcome||1. Bias, percision, limits of agreement;|
2. Percentage of error, Bland altman plot.
Grouped measurements of cardiac output derived from PAC and waveform analysis are performed in triplets, and averaged. Before and after therapeutic interventions in ICU, before and after fluid challenge, before and after changing inotropes, like vasodialition drugs.
|- Secondary outcome||N/A|
|- Timepoints||Power analysis after 8 patients.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Marcel A Leeuw, de|
|- CONTACT for SCIENTIFIC QUERIES|| Cornelis Slagt|
|- Sponsor/Initiator ||Zaans Medisch Centrum|
(Source(s) of Monetary or Material Support)
|Zaans Medisch Centrum|
|- Brief summary||During the progress of organ failure in critical ill patients often it is unclear whether the patient is adequately fluid resuscitated. To facilitate optimal fluid resuscitation cardiac output is measured by either using an invasive pulmonary artery catheter or a less invasive device. A new minimal invasive technique has become available. Cardiac output measured by arterial pressure waveform (APCO) analysis without manual calibration, the FloTrac/VigileoTM system Edwards Lifesciences. Since its launch there have been three software updates. The cardiac output derived from the arterial waveform analysis of the two latest versions showed good agreements when compared to pulmonary artery catheter under stable haemodynamic conditions [1,2]. In septic shock the bias has been improved with introduction of the 1.10 version of the software (unpublished data). Only recently the newest software version has been released (3.02).|
The aim of the study is to determine whether cardiac output measurements obtained using APCO are comparable with those obtained using intermitted thermodilution cardiac output in critical ill patients.
|- Main changes (audit trail)|
|- RECORD||12-okt-2009 - 31-okt-2009|