Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Prevention of acute kidney injury
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Hospitalized patients submitted to orthotopic heart transplantation (HT)
Exclusion Criteria
- •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)
Arms & Interventions
Hypertonic Saline Solution 3,5% (HSS)
Intervention: Sodium chloride solution 3,5% (Drug)
Normal Saline Solution (NS)
Intervention: Sodium chloride solution 0,9% (Drug)
Outcomes
Primary Outcomes
Prevention of acute kidney injury
Time Frame: Days 3 -7 post-transplantation
Demonstrate a peak value of creatinine 30% lower in the active arm
Secondary Outcomes
- Incidence of right ventricular dysfunction(Until day 5 post-transplantation)
- Mortality(30 days)
- Incidence of acute kidney injury requiring hemodialysis(30 days)
- Intensive care unit (ICU) length of stay(During ICU stay, an average of 5 days)
- Time to wean inotropes and vasopressors(During ICU stay, an average of 5 days)
- Hypertonic saline solution (HSS) hemodynamic effect(Until day 3 post-transplantation)
- Difference in loop diuretic efficiency between groups(Days 1 -3 post-transplantation)
Investigators
Fernando Bacal
Director of Heart Transplant Unit (Heart Institute).
University of Sao Paulo General Hospital