Heart TransplantationPhase 2HSS-HTxNCT05909150
Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
A Phase 2 study testing Sodium chloride solution 3,5% and Sodium chloride solution 0,9% in people with Heart Transplantation and Acute Kidney Injury, run by Fernando Bacal at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Transplantation, Acute Kidney Injury
- What is being tested?
- Sodium chloride solution 3,5% and Sodium chloride solution 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Nov 2023to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hospitalized patients submitted to orthotopic heart transplantation (HT)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Núcleo Transplante Heart Institute / University of Sao Paulo contact
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute, University of São Paulo.
São Paulo
Ciro M Murad, MD, ciromurad@hotmail.com
About this study
Official title: Use of 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.
Read the detailed description
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.
- Conditions
- Heart Transplantation, Acute Kidney Injury
- Being tested
- Sodium chloride solution 3,5%, Sodium chloride solution 0,9%
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline Solution 3,5% (HSS) | Active comparator | Not described Receives: Drug: Sodium chloride solution 3,5% |
| Normal Saline Solution (NS) | Placebo comparator | Not described Receives: Drug: Sodium chloride solution 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of acute kidney injury
Demonstrate a peak value of creatinine 30% lower in the active arm
Measured: Days 3 -7 post-transplantation
Secondary outcomes (7)
Mortality
Incidence of all cause mortality during the first 30 days after start of the study
Measured: 30 days
Incidence of acute kidney injury requiring hemodialysis
Rate of patients which required hemodialysis during the first 30 days after start of the study
Measured: 30 days
Intensive care unit (ICU) length of stay
The time frame between start of the study and ICU discharge will be calculated.
Measured: During ICU stay, an average of 5 days
Time to wean inotropes and vasopressors
Time to wean all inotropes and vasopressors will be calculated.
Measured: During ICU stay, an average of 5 days
Incidence of right ventricular dysfunction
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)
Measured: Until day 5 post-transplantation
Hypertonic saline solution (HSS) hemodynamic effect
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)
Measured: Until day 3 post-transplantation
Difference in loop diuretic efficiency between groups
Loop diuretic efficiency will be defined as cumulative urine output (mL) divided by cumulative dose of furosemide (mg), expressed as mL/mg.
Measured: Days 1 -3 post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 Nov 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fernando Bacal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernando Bacal, University of Sao Paulo General Hospital
- Investigators
- Fernando Bacal, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909150
- Sponsor's protocol ID
- HSS-HTx
- Acronym
- HSS-HTx
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
- ClinicalTrials.gov ID
- NCT05909150
- Acronym / sponsor ID
- HSS-HTx / HSS-HTx
- Conditions
- Heart Transplantation, Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Fernando BacalUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients submitted to orthotopic heart transplantation (HT)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium chloride solution 3,5%Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation. | Drug | Hypertonic Saline Solution 3,5% (HSS) |
| Sodium chloride solution 0,9%Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation. | Drug | Normal Saline Solution (NS) |
Primary outcome
Prevention of acute kidney injury
Time frame: Days 3 -7 post-transplantation
Demonstrate a peak value of creatinine 30% lower in the active arm
7 secondary outcomes
Mortality
Time frame: 30 days
Incidence of acute kidney injury requiring hemodialysis
Time frame: 30 days
Intensive care unit (ICU) length of stay
Time frame: During ICU stay, an average of 5 days
Time to wean inotropes and vasopressors
Time frame: During ICU stay, an average of 5 days
Incidence of right ventricular dysfunction
Time frame: Until day 5 post-transplantation
Hypertonic saline solution (HSS) hemodynamic effect
Time frame: Until day 3 post-transplantation
Difference in loop diuretic efficiency between groups
Time frame: Days 1 -3 post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Related trials for Heart Transplantation
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
LVAD (Left Ventricular Assist Device) Thrombosis, Heart Failure
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Núcleo Transplante Heart Institute / University of Sao Paulo contact
Fernando Bacal, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium chloride solution 3,5% and Sodium chloride solution 0,9% in people with Heart Transplantation and Acute Kidney Injury, run by Fernando Bacal at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ciro M Murad, MD (+55 31988988843, ciromurad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of acute kidney injury (time frame: Days 3 -7 post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.