Medical Center Leeuwarden
Leeuwarden, 8904 BR, Netherlands
NCT Number: NCT03806582
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Leeuwarden, 8904 BR, Netherlands
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intervention with norepinephrine to reach a MAP of 85 mmHg
Time frame: 2 hours postoperative
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 parameters of RV and LV contractility
Time frame: baseline and 15 minutes postoperatively
RV end-diastolic pressure pre and post intervention
Time frame: 2 hours postoperative
Difference in cardiac index between intervention and control groups
Time frame: 2 hours postoperative
Difference in fluid balance between intervention and control groups
Frisius Medisch Centrum
Other
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