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Can a novel perfusion monitor help us defining optimal flow for patients on cardiopulmonary bypass.


- candidate number17554
- NTR NumberNTR4596
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2014
- Secondary IDs2014/017 MEC UZ Brussel
- Public TitleCan a novel perfusion monitor help us defining optimal flow for patients on cardiopulmonary bypass.
- Scientific TitleCan a novel perfusion monitor help us defining optimal flow for patients on cardiopulmonary bypass.
- ACRONYMN/A
- hypothesisEvaluation of the golden standard in perfusion by using a perfusion monitor to evaluate adequate oxygen delivery.
- Healt Condition(s) or Problem(s) studiedCardiopulmonary Bypass (CPB), Cardiovascular disease, Post-operative complications
- Inclusion criteria-Patients scheduled for cardiac surgery.
-Normothermic cases and maximum duration less than 2 hours.
- Exclusion criteria-Complicated cases
-CPB duration over 2 hours
-renal insufficiency
-emergency
-reanimation
-salvage and existing inflammatory conditions.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 17-feb-2014
- planned closingdate17-feb-2015
- Target number of participants150
- InterventionsArterial and venous connector for inline measurement. Regular blood gas analysis. Blood flow sensor measurement.
- Primary outcomeWhich oxygen flow gives hyperlactatemia?
- Secondary outcomeEvaluation of kidney function.
- Timepoints1) Blood gas before cardiopulmonary bypass(CPB), after 10', 30', 60', 90', 120' and post CPB.
2) Postoperative we will also look at the highest lactate level during hospital stay.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Veerle Mossevelde, van
- CONTACT for SCIENTIFIC QUERIES Kurt Staessens
- Sponsor/Initiator Universitair Ziekenhuis Brussel
- Funding
(Source(s) of Monetary or Material Support)
Universitair Ziekenhuis Brussel
- PublicationsN/A
- Brief summaryAdequate oxygen delivery (D02) to the organs and tissues of the cardiovascular patient is the primary principle of putting patients on cardiopulmonary bypass (CPB). The golden standard for calculation of flow is 2,4 L/min/m2 body surface area (BSA). Blood flow during CPB is standardized worldwide; i.e. 2,2-2,5 LPM/m2. There is an increasing tendency towards a more individual circulatory treatment. In fact, individualized goal-directed therapy has been shown to reduce postoperative complications and mortality in high-risk surgery. Hypo-perfusion (defined as the inadequate delivery of oxygen) and the resulting Hyperlactatemia are well described and quantified, as well as their postoperative consequences. The effects of hyper-perfusion are far less investigated.
A new perfusion monitor is developed to continuously monitor, in real-time and online, the different determinants of oxygen delivery and oxygen consumption of the patient.
- Main changes (audit trail)
- RECORD23-apr-2014 - 10-jun-2014


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