Right ventricular (RV) dysfunction in cardiac surgery is an independent risk factor for morbidity and mortality. Raising the systemic blood pressure with norepinephrine seems to have a positive influence on the right ventricular function in several animal studies. The current study is designed to evaluate the effect of a higher blood pressure on the RV function in post cardiac surgery patients.
Goal: To demonstrate differences in RV function by raising the systemic blood pressure with norepinephrine. Study design: randomized controlled trial Study population: 78 postoperative cardiac surgery patients admitted at the ICU. Intervention: * Group 1: (N=22): RVEF\<20% and MAP≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours. * Group 2: (N=22): RVEF \<20% and MAP≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg. * Group 3: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Intervention with norepinephrine to reach a MAP of 85mmHg for a maximum duration of two hours. * Group 4: (N=17): RVEF between ≥20 and \<30% and MAP ≤65mmHg. Control group: treatment according to current standards. Hypotensive patients are treated with fluids and/or vasopressors to gain a mean arterial pressure (MAP) of 65mmHg. Endpoints: Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF. Secondary endpoints are the echocardiographic parameters of RV and LV contractility, RV end-diastolic pressure, cardiac index, and fluid balance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
78
intervention with norepinephrine to reach a MAP of 85 mmHg
Medical Center Leeuwarden
Leeuwarden, Netherlands
right ventricular ejection fraction
Primary endpoint is the difference between the intervention and the control group in the change over time between baseline and the end of the study period (T4) in RVEF.
Time frame: 2 hours postoperative
Echocardiographic
Echocardiographic parameters of RV and LV contractility
Time frame: 2 hours postoperative
RV end-diastolic pressure
RV end-diastolic pressure pre and post intervention
Time frame: baseline and 15 minutes postoperatively
Cardiac index
Difference in cardiac index between intervention and control groups
Time frame: 2 hours postoperative
Fluid balance
Difference in fluid balance between intervention and control groups
Time frame: 2 hours postoperative
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