Actively Recruiting
Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Led by Fernando Bacal · Updated on 2026-05-06
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether hypertonic saline solution can prevent or lessen acute kidney injury (AKI) shortly after heart transplantation. AKI is a common complication within the first days after this surgery, affecting 40-70% of patients due to factors like excess fluid, hormone system activation, and low heart output. This Phase 2 randomized study aims to explore if hypertonic saline can improve kidney outcomes in this critical period after heart transplant. Participants will be randomly assigned to receive either 150 mL of hypertonic saline solution (3.5%) or a placebo normal saline solution (0.9%) intravenously twice daily for three days following the heart transplant. The study compares these two treatments to see their effects on kidney function and heart performance. Patients will be monitored closely for 30 days or until death. During the study, kidney function, echocardiograms of the right heart, and measurements from pulmonary artery catheters will be assessed. Researchers will track outcomes such as the occurrence of acute kidney injury by days 3 to 7 post-transplant, mortality within 30 days, need for dialysis, time spent in intensive care, heart function, and response to diuretics. This detailed monitoring helps evaluate the impact of the treatment on early post-transplant recovery and kidney protection.
CONDITIONS
Brief Title
Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized patients submitted to orthotopic heart transplantation (HT)
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants receive 150 mL of hypertonic saline solution 3.5% or placebo twice daily for 3 days after heart transplantation to prevent acute kidney injury.
Twice daily intravenous administration for 3 days
Duration - Up to 30 days
Participants are monitored for outcomes including kidney function, mortality, and recovery for up to 30 days after transplantation.
Follow-up assessments until day 30 post-transplantation
Trial Site Locations
Total: 1 location
1
Heart Institute, University of São Paulo.
São Paulo, Brazil
Actively Recruiting
Research Team
C
Ciro M Murad, MD
N
Núcleo Transplante Heart Institute / University of Sao Paulo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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