The goal of this study is to evaluate if hypertonic saline solution can prevent or attenuate acute kidney injury after heart transplantation in the early postoperative phase.
Acute kidney injury (AKI) is a frequent complication immediately after heart transplantation (HT), with incidence rates between 40-70%. Several factors contribute to this complication, such as hypervolemia, hyperactivation of renin-angiotensin-aldosterone system (RASS) and low cardiac output. Hypertonic saline solution (HSS) can reduce diuretic resistance, increase urinary output and improve renal function in hypervolemic status such as acute heart failure. Therefore, the investigators hypothesized that the use of HSS could prevent or attenuate AKI after heart transplantation in the early postoperative phase. The investigators aim to randomize 74 patients to receive 150 mL of HSS 3,5% or placebo (saline solution 0,9%) twice daily for 3 days after HT. Renal function, right ventricular echocardiographic parameters and pulmonary artery catheter parameters will be assessed. Patients will be followed-up until 30 days, or death.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.
Heart Institute, University of São Paulo.
São Paulo, Brazil
RECRUITINGPrevention of acute kidney injury
Demonstrate a peak value of creatinine 30% lower in the active arm
Time frame: Days 3 -7 post-transplantation
Mortality
Incidence of all cause mortality during the first 30 days after start of the study
Time frame: 30 days
Incidence of acute kidney injury requiring hemodialysis
Rate of patients which required hemodialysis during the first 30 days after start of the study
Time frame: 30 days
Intensive care unit (ICU) length of stay
The time frame between start of the study and ICU discharge will be calculated.
Time frame: During ICU stay, an average of 5 days
Time to wean inotropes and vasopressors
Time to wean all inotropes and vasopressors will be calculated.
Time frame: During ICU stay, an average of 5 days
Incidence of right ventricular dysfunction
Right ventricular dysfunction will be assessed through the following echocardiographic parameters: * Tricuspid annular plane systolic excursion (TAPSE; normal ≥1.7 cm); * Tricuspid annular velocity (S') (normal ≥9.5 cm/s); * Fractional area change (FAC; normal ≥35 percent); * Right Ventricle basal diameter (normal ≤4.1 cm)
Time frame: Until day 5 post-transplantation
Hypertonic saline solution (HSS) hemodynamic effect
Pulmonary artery catheter measures will be assessed before HSS infusion, immediately after HSS infusion and 30 min after HSS infusion. The following measures will be assessed: * Right atrial pressure (RAP) * Systolic pulmonary artery pressure (sPAP) * Diastolic pulmonary artery pressure (dPAP) * Mean pulmonary artery pressure (mPAP) * Pulmonary artery wedge pressure (PCWP) * Cardiac output (CO)
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Time frame: Until day 3 post-transplantation
Difference in loop diuretic efficiency between groups
Loop diuretic efficiency will be defined as cumulative urine output (mL) divided by cumulative dose of furosemide (mg), expressed as mL/mg.
Time frame: Days 1 -3 post-transplantation