This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery. Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included. Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg). Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Reanimation Cardiovasculaire Et Thoracique
La Tronche, Grenoble, France
Right ventricular ejection fraction change measured by Swan Ganz catheter.
Time frame: after 30 minutes perfusion ( fluid expansion)
Left ventricular contractility
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Systolic volume change
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Cardiac output evolution.
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Tricuspid annular plane systolic excursion assessment
Time frame: One hour before and after perfusion
Continuous cardiac output
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Blood volume efficiency
Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure
Time frame: One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion
Plasmatic volume monitoring
Plasmatic volume augmentation assessed by hemoglobin decrease
Time frame: One hour before and , 1, 6 and 18 hours after perfusion
Natremia level
Time frame: at 1, 6 and 18 hours after perfusion
Veinous oxygen saturation
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Mean arterial pressure assessment.
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Lactatemia level
Time frame: at 1, 6 and 18 hours after perfusion
Acid base balance assessment.
Time frame: at 1, 6 and 18 hours after perfusion
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