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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline Solution 3,5% (HSS) | Active Comparator |
| |
| Normal Saline Solution (NS) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium chloride solution 3,5% | Drug | Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of acute kidney injury | Demonstrate a peak value of creatinine 30% lower in the active arm | Days 3 -7 post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Incidence of all cause mortality during the first 30 days after start of the study | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ciro M Murad, MD | Contact | +55 31988988843 | ciromurad@hotmail.com | |
| Núcleo Transplante Heart Institute / University of Sao Paulo | Contact | +55 1126615720 |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Bacal, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute, University of São Paulo. | Recruiting | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Sodium chloride solution 0,9% | Drug | Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation. |
|
| 30 days |
| Intensive care unit (ICU) length of stay | The time frame between start of the study and ICU discharge will be calculated. | During ICU stay, an average of 5 days |
| Time to wean inotropes and vasopressors | Time to wean all inotropes and vasopressors will be calculated. | During ICU stay, an average of 5 days |
| Incidence of right ventricular dysfunction | Right ventricular dysfunction will be assessed through the following echocardiographic parameters:
| 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:
| 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. | Days 1 -3 post-transplantation |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |