Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

NCT05909150 | Recruiting Phase 2

• 1 other identifier: HSS-HTx
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Prevention of acute kidney injury

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

  Days 3 -7 post-transplantation

Secondary Outcomes (7)

• Mortality

  30 days

• Incidence of acute kidney injury requiring hemodialysis

  30 days

• Intensive care unit (ICU) length of stay

  During ICU stay, an average of 5 days

• Time to wean inotropes and vasopressors

  During ICU stay, an average of 5 days

• Incidence of right ventricular dysfunction

  Until day 5 post-transplantation

Study Arms (2)

Hypertonic Saline Solution 3,5% (HSS)

ACTIVE COMPARATOR

Drug: Sodium chloride solution 3,5%

Normal Saline Solution (NS)

PLACEBO COMPARATOR

Drug: Sodium chloride solution 0,9%

Interventions

Sodium chloride solution 3,5% DRUG

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

Hypertonic Saline Solution 3,5% (HSS)

Sodium chloride solution 0,9% DRUG

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

Normal Saline Solution (NS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients submitted to orthotopic heart transplantation (HT)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fernando Bacal: lead

Study Sites (1)

Heart Institute, University of São Paulo.

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fernando Bacal, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Central Study Contacts

Ciro M Murad, MD

CONTACT

+55 31988988843; ciromurad@hotmail.com

Núcleo Transplante Heart Institute / University of Sao Paulo

CONTACT

+55 1126615720

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Heart Transplant Unit (Heart Institute).

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: June 18, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

BR (1)