An interventional study of 50-100ug phenylephrine before CPB and 50-100ug phenylephrine during CPB in Cerebral Perfusion, Cerebral Oxygenation and Cardiopulmonary Bypass, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-08.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Basic science
The purpose of this study is to determine whether cerebral blood flow and cerebral tissue oxygenation is most dependent on cardiac output or on mean arterial pressure in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.
UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
All patient undergo the 5 different intervention in a randomised matter.
Other: 50-100ug phenylephrine before CPB · Other: 50-100ug phenylephrine during CPB · Other: decreasing CPB flow · Other: Decreasing CPB flow AND 50-100ug phenylephrine · Other: Increasing CPB flow
In this intervention we will administer 50-100 μg phenylephrine to the patient before CPB is started. This intervention will take place when the patient shows hypotension (MAP \<60mmHg, according to protocol22). Because of the increase in PVR there will be a baroreceptor-reflex-mediated decrease in CO. On-line, we will quantify the percentage decrease in systemic blood flow (i.e. CO) by using the Modelflow algoritm incorporated in a non-invasive beat-to-beat finger blood pressure monitor. This will allow us to obtain a reference for the decrease in CO to use in the next interventions. Our hypothesis is that CO will decrease because of the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
In this intervention we will induce only 1 component of the changes at intervention (1), being the increase in MAP of approximately 20 mmHg by administrating 50-100 μg phenylephrine. The CPB enables us to maintain a constant CO and thus eliminating the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
With this intervention we will only create a change in CO, which enables us to eliminate the effect of blood pressure. We will modify CPB flow to achieve the CO decrease (in %) measured at intervention (1) meaning: pre-CPB after the bolus of 50-100 μg phenylephrine. In the case of unexpected increase (in %) of CO measured at intervention (1), we will still decrease CPB flow so we will be able to analyse decrease as well as increase in CPB flow. During this intervention NIRS and TCD MCA will be recorded.
In this intervention we will simulate the 'normal' physiological state when administering phenylephrine. We will modify CPB flow to achieve the percentage change CO as observed during intervention (1) as well as administrate 50-100 μg phenylephrine. We expect to see similar outcomes as in intervention (1). During this intervention NIRS and TCD MCA will be recorded.
In this last intervention we will create an increase in MAP without using phenylephrine but only by increasing CO. This enables us to eliminate a possible direct α1-adrenergic effect on the cerebral vasculature. MAP will be raised approximately 20 mmHg by increasing CPB flow 20%. During this intervention NIRS and TCD MCA will be recorded.
regional cerebral oxygen saturation
Time frame: During surgery
mean velocity of blood flow of the middle cerebral artery
Time frame: During surgery
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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UMC Utrecht