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NCT Number: NCT05909150

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.

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Key information

Conditions

Heart Transplantation Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heart Institute, University of São Paulo.

São Paulo, Brazil

Location status: Recruiting

Location contact

Ciro M Murad, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium chloride solution 3,5%

Drug

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

Sodium chloride solution 0,9%

Drug

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

Primary outcomes

  1. Prevention of acute kidney injury

    Time frame: Days 3 -7 post-transplantation

    Demonstrate a peak value of creatinine 30% lower in the active arm

Secondary outcomes

  1. Mortality

    Time frame: 30 days

    Incidence of all cause mortality during the first 30 days after start of the study

  2. 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

  3. 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.

  4. 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.

  5. 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)

  6. 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)

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ciro M Murad, MD

CONTACT

[email protected]

+55 31988988843

Núcleo Transplante Heart Institute / University of Sao Paulo

CONTACT

+55 1126615720

Sponsors and collaborators

Lead sponsor

Fernando Bacal

Other

Registry information

Official study title

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

Acronym: HSS-HTx

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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