Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
- Conditions
- Heart TransplantationAcute Kidney Injury
- Interventions
- Drug: Sodium chloride solution 3,5%Drug: Sodium chloride solution 0,9%
- Registration Number
- NCT05909150
- Lead Sponsor
- Fernando Bacal
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
- Hospitalized patients submitted to orthotopic heart transplantation (HT)
- Requirement of renal replacement therapy at the time of HT
- Requirement of extracorporeal membrane oxygenation (ECMO) before or immediately after HT
- Severe peri-operative mechanical complications
- Double transplant (e.g. heart-kidney or heart-lung)
- Hypernatremia (Na ≥ 145)
- Severe hyponatremia (Na ≤ 120)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypertonic Saline Solution 3,5% (HSS) Sodium chloride solution 3,5% - Normal Saline Solution (NS) Sodium chloride solution 0,9% -
- Primary Outcome Measures
Name Time Method Prevention of acute kidney injury Days 3 -7 post-transplantation Demonstrate a peak value of creatinine 30% lower in the active arm
- Secondary Outcome Measures
Name Time Method Incidence of right ventricular dysfunction Until day 5 post-transplantation 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)Mortality 30 days Incidence of all cause mortality during the first 30 days after start of the study
Incidence of acute kidney injury requiring hemodialysis 30 days Rate of patients which required hemodialysis during the first 30 days after start of the study
Intensive care unit (ICU) length of stay During ICU stay, an average of 5 days The time frame between start of the study and ICU discharge will be calculated.
Time to wean inotropes and vasopressors During ICU stay, an average of 5 days Time to wean all inotropes and vasopressors will be calculated.
Hypertonic saline solution (HSS) hemodynamic effect Until day 3 post-transplantation 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)
Trial Locations
- Locations (1)
Heart Institute, University of São Paulo.
🇧🇷São Paulo, Brazil