Using hypertonic saline to prevent kidney injury after heart transplantation
Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
This study is testing if a special salt solution can help prevent kidney problems in people who are having heart transplants.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT05909150 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients who are undergoing orthotopic heart transplantation.
Not a fit: Patients requiring renal replacement therapy or those with severe peri-operative complications will not benefit from this study.
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 performed: While the use of hypertonic saline in this context is novel, similar approaches have shown promise in other settings, suggesting potential for success.
Eligibility criteria
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 this trial is running
São Paulo
- Heart Institute, University of São Paulo. — São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Ciro M Murad, MD
- Email: ciromurad@hotmail.com
- Phone: +55 31988988843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.