Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Using hypertonic saline to prevent kidney injury after heart transplantation

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

Run by University of Sao Paulo General Hospital · NCT05909150 · Data updated 2026-11-12

This study is testing if a special salt solution can help prevent kidney problems in people who are having heart transplants.

More Acute Kidney Injury trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment74 (estimated)
SponsorUniversity of Sao Paulo General Hospital
Academic / other
Locations1 site (São Paulo)
StatusRecruiting
StartedNovember 8, 2023
Main results expectedMarch 2027
Study endsMarch 2027
Registry record updatedMay 6, 2026
Trial IDNCT05909150 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are hospitalized patients who are undergoing orthotopic heart transplantation.

Probably not a fit

Patients requiring renal replacement therapy or those with severe peri-operative complications will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of hypertonic saline solution in preventing acute kidney injury (AKI) in patients undergoing heart transplantation. The trial will randomize 74 patients to receive either hypertonic saline or a placebo for three days post-surgery. The researchers will monitor renal function and other cardiac parameters to assess the impact of the treatment. The goal is to determine if hypertonic saline can mitigate the high incidence of AKI observed in the early postoperative phase.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in heart transplant patients, improving their recovery and long-term outcomes.

How similar studies have gone: While the use of hypertonic saline in this context is novel, similar approaches have shown promise in other settings, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.