This trial will consist of two parts: A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the design of the final study. The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Ritodrine (Pre-Par), maximum 400 µg/minute, IV
Atosiban (Tractocile), maximum 300 µg/minute, IV
Glucose 5%, IV
University Hospital Ghent
Ghent, Belgium
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the level of arterial stiffness
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance
Time frame: 240 minutes
Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure
Time frame: 240 minutes
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