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

April 29, 2026 updated by: Fernando Bacal

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Núcleo Transplante Heart Institute / University of Sao Paulo
  • Phone Number: +55 1126615720

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Heart Institute, University of São Paulo.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypertonic Saline Solution 3,5% (HSS)
Drug: Sodium chloride solution 3,5%
Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
Placebo Comparator: Normal Saline Solution (NS)
Drug: Sodium chloride solution 0,9%
Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of acute kidney injury
Time Frame: Days 3 -7 post-transplantation
Demonstrate a peak value of creatinine 30% lower in the active arm
Days 3 -7 post-transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Incidence of all cause mortality during the first 30 days after start of the study
30 days
Incidence of acute kidney injury requiring hemodialysis
Time Frame: 30 days
Rate of patients which required hemodialysis during the first 30 days after start of the study
30 days
Intensive care unit (ICU) length of stay
Time Frame: During ICU stay, an average of 5 days
The time frame between start of the study and ICU discharge will be calculated.
During ICU stay, an average of 5 days
Time to wean inotropes and vasopressors
Time Frame: During ICU stay, an average of 5 days
Time to wean all inotropes and vasopressors will be calculated.
During ICU stay, an average of 5 days
Incidence of right ventricular dysfunction
Time Frame: Until day 5 post-transplantation

Right ventricular dysfunction will be assessed through the following echocardiographic parameters:

  • Tricuspid annular plane systolic excursion (TAPSE; normal ≥1.7 cm);
  • Tricuspid annular velocity (S') (normal ≥9.5 cm/s);
  • Fractional area change (FAC; normal ≥35 percent);
  • Right Ventricle basal diameter (normal ≤4.1 cm)
Until day 5 post-transplantation
Hypertonic saline solution (HSS) hemodynamic effect
Time Frame: Until day 3 post-transplantation

Pulmonary artery catheter measures will be assessed before HSS infusion, immediately after HSS infusion and 30 min after HSS infusion.

The following measures will be assessed:

  • Right atrial pressure (RAP)
  • Systolic pulmonary artery pressure (sPAP)
  • Diastolic pulmonary artery pressure (dPAP)
  • Mean pulmonary artery pressure (mPAP)
  • Pulmonary artery wedge pressure (PCWP)
  • Cardiac output (CO)
Until day 3 post-transplantation
Difference in loop diuretic efficiency between groups
Time Frame: Days 1 -3 post-transplantation
Loop diuretic efficiency will be defined as cumulative urine output (mL) divided by cumulative dose of furosemide (mg), expressed as mL/mg.
Days 1 -3 post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fernando Bacal

Investigators

  • Study Director: Fernando Bacal, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSS-HTx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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