NCT05909150 Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
| NCT ID | NCT05909150 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fernando Bacal |
| Condition | Heart Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 74 participants in total. It began in 2023-11-08 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Fernando Bacal, PhD
STUDY DIRECTOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT05909150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05909150 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05909150 currently recruiting?
Yes, NCT05909150 is actively recruiting participants. Contact the research team at ciromurad@hotmail.com for enrollment information.
Where is the NCT05909150 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT05909150 clinical trial?
NCT05909150 is sponsored by Fernando Bacal. The principal investigator is Fernando Bacal, PhD at University of Sao Paulo. The trial plans to enroll 74 participants.