Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-08

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Heart Transplantation Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hypertonic Saline Solution 3,5% (HSS)

Group Type ACTIVE_COMPARATOR

Sodium chloride solution 3,5%

Intervention Type DRUG

Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.

Normal Saline Solution (NS)

Group Type PLACEBO_COMPARATOR

Sodium chloride solution 0,9%

Intervention Type DRUG

Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

Interventions

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Sodium chloride solution 3,5%

Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.

Intervention Type DRUG

Sodium chloride solution 0,9%

Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes