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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.


- candidate number6580
- NTR NumberNTR2072
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-okt-2009
- Secondary IDsM09-035 METC Noord Holland
- Public TitleComparison 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 TitleCardiac 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.
- ACRONYM
- hypothesisThe 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) studiedSeptic shock , Dynamic hemodynamic profiles
- Inclusion criteria1. Sinus Rhythm;
2. Septic Shock;
3. Inotropic support including Noradrenalin;
4. PA Catheter;
5. Informed consent.
- Exclusion criteria1. Non sinus rhythm;
2. No informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-jan-2009
- planned closingdate9-jan-2010
- Target number of participants15
- InterventionsN/A
- Primary outcome1. 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 outcomeN/A
- TimepointsPower analysis after 8 patients.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Marcel A Leeuw, de
- CONTACT for SCIENTIFIC QUERIES Cornelis Slagt
- Sponsor/Initiator Zaans Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
Zaans Medisch Centrum
- PublicationsN/A
- Brief summaryDuring 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)
- RECORD12-okt-2009 - 31-okt-2009


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