|- candidate number||12196|
|- NTR Number||NTR3399|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-apr-2012|
|- Secondary IDs||MH011.213 METC Noord Holland|
|- Public Title||Vergelijking van het hartminuut volume gemeten met de standaard methode ten op zichte van het hartminuut volume gemeten middels een methode met behulp van de slagader in de lies bij ernstig zieke patiŽnten op de intensive care.|
|- Scientific Title||Cardiac output measured by arterial pressure waveform analysis compared with transpulmonary or intermittent bolus thermodilution in critical ill patients.|
|- hypothesis||The aim of the study is to determine whether cardiac output measurements obtained using APCO are comparable with those obtained using transpulmonary (advanced FloTrac software) and intermitted bolus thermodilution cardiac output in critical ill patients.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||1. Adult patients requiring advanced hemodynamic monitoring as part of standard clinical care in critically ill patients;|
2. Femoral arterial line.
|- Exclusion criteria||1. Age < 18 years;|
2. Severe tricuspid regurgitation;
3. Aortic regurgitation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2011|
|- planned closingdate||1-feb-2013|
|- Target number of participants||20|
|- Interventions||Comparing Cardiac Output, measured by pulmonary artery catheter or Trans pulmonary thermodilution (advanced hemodynamic monotoring) with Arterial Pressure Waveform Analysis without callibration.|
APWA is less invasive but has shown to underestimate CO when patients are sepsic. APWA usses the same technique but requires caliration.
PAC is golden standard but very invasive.
|- Primary outcome||1. Bias percision;|
2. Limits of agreement;
3. Percentage of error;
4. Bland altman plot.
|- Secondary outcome||N/A|
|- Timepoints||Interim analysis after 5 patients (jan 2012).|
METC noord-holland NH012.051: (7 febr 2012) 15 extra patients are allowed to be included.
|- 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 it is often 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 (PAC) 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 four 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). In summary, during low systemic vascular resistance (SVR), the difference between APCO and PAC increases when SVR decreases. The latest improvement has been a external transpulmonary calibration of part the FloTrac algorithme with the intention to reduce the error seen under low SVR conditions. This study is a continuem of our previous research in sepsis and cardiac output measurements . Our recent findings using the 3.02 software version are submitted for publication.|
|- Main changes (audit trail)|
|- RECORD||4-apr-2012 - 26-apr-2012|