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Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Heart Institute, University of São Paulo.
São Paulo, Brazil
Start Date
November 8, 2023
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
March 25, 2025
74
ESTIMATED participants
Sodium chloride solution 3,5%
DRUG
Sodium chloride solution 0,9%
DRUG
Lead Sponsor
Fernando Bacal
NCT05806645
NCT07472426
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07447791