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Perioperatief behoud van de globale weefselperfusie en volemische status tijdens abdominale chirurgie: Nexfin hartminuutvolume en pulse pressure variatie versus arteriŽle bloeddruk-gestuurde therapie.


- candidate number10976
- NTR NumberNTR3250
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2012
- Secondary IDs2011/249 METC VUmc
- Public TitlePerioperatief behoud van de globale weefselperfusie en volemische status tijdens abdominale chirurgie: Nexfin hartminuutvolume en pulse pressure variatie versus arteriŽle bloeddruk-gestuurde therapie.
- Scientific TitlePerioperative maintenance of global tissue perfusion and volemic state in abdominal surgery: Nexfin cardiac output and pulse pressure variation versus arterial blood pressure-guided therapy.
- ACRONYMCOGUIDE
- hypothesisPerioperative maintenance of cardiac output and pulse pressure variation result in an overall reduction in postoperative complications when compared to arterial blood pressure-guided perioperative hemodynamics in patients undergoing elective abdominal surgery.
- Healt Condition(s) or Problem(s) studiedAbdominal surgery
- Inclusion criteria1. Patients undergoing elective abdominal surgery;
2. Age 18-85 years;
3. Duration of surgery > 90 minutes;
4. Informed consent.
- Exclusion criteria1. Preexisting cardiac arrhythmias;
2. Emergency operation;
3. ICU patients;
4. Body mass index below 20 kg/m2 and above 40 kg/m2;
5. Patients without an invasive arterial line;
6. Decompensatio cordis;
7. Aortic valve disease;
8. Ejection fraction < 0.3;
9. Aortic valve stenosis: surface < 1.2 cm2;
10. Pulmonary arterial pressure > 30 mm Hg, TAPSE < 18 mm;
11. Incapacitated patients.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jan-2012
- planned closingdate31-okt-2013
- Target number of participants250
- InterventionsHemodynamic guidance based on arterial blood pressure or cardiac output with pulse pressure variation.
1. Mean Arterial Pressure (MAP), measured with a non-invasive continuous arterial sphygmomanometer;
2. Pulse Pressure Variance (PPV), also measured with a non-invasive continuous arterial sphygmomanometer.
- Primary outcomeThe primary endpoint is defined as postoperative morbidity based on the incidence of a number of predefined complications until 7 days after surgery. These parameters include, among others, reoperation, infections, rehabilitation and restoration of gastrointestinal function.
- Secondary outcomeSecondary endpoints include hospital length of stay and microcirculatory perfusion.
- TimepointsPerioperative and 7 days following surgery.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Christa Boer
- CONTACT for SCIENTIFIC QUERIESDr. Christa Boer
- Sponsor/Initiator VU University Medical Center, Westfriesgasthuis Hoorn
- Funding
(Source(s) of Monetary or Material Support)
BMEYE BV, the Netherlands
- PublicationsN/A
- Brief summaryThis investigation is based on the hypothesis that perioperative guidance of global tissue perfusion and volemic state by cardiac output and pulse pressure variation is associated with less postoperative complications than arterial blood pressure-guided therapy in patients undergoing abdominal surgery. In the present study we therefore aim to compare these two strategies of perioperative hemodynamic optimization to evaluate the effects of both strategies on patient outcome.
- Main changes (audit trail)
- RECORD19-jan-2012 - 7-jan-2016


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