Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation (HSS-HT)

Fernando Bacal

Status and phase: Enrolling; Phase 2

Conditions: Acute Kidney Injury; Heart Transplantation

Treatments: Drug: Sodium chloride solution 0,9%; Drug: Sodium chloride solution 3,5%

Study type: Interventional

Funder types: Other

Identifiers

NCT05909150

HSS-HT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Hypertonic Saline Solution 3,5% (HSS)

Active Comparator group

Treatment:

Drug: Sodium chloride solution 3,5%

Normal Saline Solution (NS)

Placebo Comparator group

Treatment:

Drug: Sodium chloride solution 0,9%