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ID
Source
Health condition
Indicatie for an extracranial-intracranial bypass: either flow augmentation for patients with steno-occlusive vascular disease such as moyamoya disease or flow preservation when a major artery has to be sacrificed to treat an underlying disease such as a tumor of the central skull base or a complex intracranial aneurysm.
Sponsors and support
Intervention
Outcome measures
Primary outcome
First, we will measure the graft flow rate to be used as a reference for graft perfusion. Afterwards the cardiac output or blood pressure is increased. Our main study parameter will be the mean (sd) change in graft flow for an increase in cardiac output compared to the reference phase and the mean (sd) change in graft flow for an increase in blood pressure, compared to the reference phase.
Secondary outcome
Secondary endpoints are the absolute difference in increase (or decrease) in graft flow rate, cardiac output and blood pressure between dobutamine and phenylephrine treatment, as compared to the reference stage.
Background summary
Patients receiving cerebral revascularization with a bypass are prone for cerebral hypoperfusion. Currently, blood pressure is often increased with vasopressors to prevent cerebral ischemia. However, this might cause vasoconstriction of the graft and cerebral vasculature. We hypothesized that cardiac output rather than blood pressure is essential for adequate cerebral perfusion and aimed to determine whether an increase in cardiac output results in higher graft perfusion (and thus cerebral perfusion) than an increase in blood pressure in patients undergoing cerebral bypass surgery. This randomized crossover monocenter study included 10 adult patients undergoing cerebral bypass surgery. Patients randomly and sequentially received dobutamine to increase the cardiac output (indexed for body surface area) and phenylephrine to increase the mean arterial blood pressure (MAP). An increase of >10% in cardiac index and >10% in MAP was targeted, respectively.
Study objective
We hypothesize that cardiac output rather than blood pressure is essential for adequate cerebral perfusion during and after cerebral revascularization.
Study design
All interventions and measurements will be done during the hemostasis phase of extracranial-intracranial bypass surgery
Intervention
Patients will receive, randomly and sequentially, dobutamine (2-15 µg/kg/min) to increase the cardiac output and phenylephrine (0.15-1 µg/kg/min) to increase the blood pressure.
A. Akkermans
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
+31887577081
a.akkermans@umcutrecht.nl
A. Akkermans
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
+31887577081
a.akkermans@umcutrecht.nl
Inclusion criteria
Adults, aged 18 years or above at day of surgery
Indication for extracranial-intracranial bypass surgery
Exclusion criteria
Patients within two weeks after a subarachnoid hemorrhage
Language barrier
Pregnancy
Hypertrophic cardiomyopathy
Left ventricular outflow tract obstruction
Severe, untreated ventricular arrhytmia
Severe hyperthyroidism
Recent myocardial infarction (<30days) or unstable angina
Hypersensitivity to dobutamine or phenylephrine
Mean arterial blood pressure < 60 mmHg under general anesthesia before start of the study period
Systolic blood pressure > 180 mmHg under general anesthesia before start of the study period
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7077 |
| NTR-old | NTR7275 |
| Other | METC UMC Utrecht : 18-321/G-M |