|- candidate number||17554|
|- NTR Number||NTR4596|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-apr-2014|
|- Secondary IDs||2014/017 MEC UZ Brussel|
|- Public Title||Can a novel perfusion monitor help us defining optimal flow for patients on cardiopulmonary bypass.|
|- Scientific Title||Can a novel perfusion monitor help us defining optimal flow for patients on cardiopulmonary bypass.|
|- hypothesis||Evaluation of the golden standard in perfusion by using a perfusion monitor to evaluate adequate oxygen delivery.|
|- Healt Condition(s) or Problem(s) studied||Cardiopulmonary 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
-salvage and existing inflammatory conditions.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||17-feb-2014|
|- planned closingdate||17-feb-2015|
|- Target number of participants||150|
|- Interventions||Arterial and venous connector for inline measurement. Regular blood gas analysis. Blood flow sensor measurement.|
|- Primary outcome||Which oxygen flow gives hyperlactatemia?|
|- Secondary outcome||Evaluation of kidney function.|
|- Timepoints||1) 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 site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Veerle Mossevelde, van|
|- CONTACT for SCIENTIFIC QUERIES|| Kurt Staessens|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel|
|- Brief summary||Adequate 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)|
|- RECORD||23-apr-2014 - 10-jun-2014|