NCT05909150

Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Fernando Bacal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Transplantation
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Sodium chloride solution 3,5%	Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
DRUG	Sodium chloride solution 0,9%	Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

Timeline

• Start date: 2023-11-08
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-06-18
• Last updated: 2025-03-25

Locations

1 site across 1 country: Brazil