HSS-HT: Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

Sponsor

Fernando Bacal (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05909150

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Transplantation Acute Kidney Injury	Drug: Sodium chloride solution 3,5% Drug: Sodium chloride solution 0,9%	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Hypertonic Saline Solution 3,5% (HSS)	Drug: Sodium chloride solution 3,5% Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
Placebo Comparator: Normal Saline Solution (NS)	Drug: Sodium chloride solution 0,9% Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

Arm

Intervention/Treatment

Active Comparator: Hypertonic Saline Solution 3,5% (HSS)

Drug: Sodium chloride solution 3,5%

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

Placebo Comparator: Normal Saline Solution (NS)

Drug: Sodium chloride solution 0,9%

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

Outcome Measures

Primary Outcome Measures

Prevention of acute kidney injury [Days 4 -7 post-transplantation]
Demonstrate a peak value of creatinine 30% lower in the active arm

Secondary Outcome Measures

Mortality [30 days]
Incidence of all cause mortality during the first 30 days after start of the study
Incidence of acute kidney injury requiring hemodialysis [30 days]
Rate of patients which required hemodialysis during the first 30 days after start of the study
Intensive care unit (ICU) length of stay [During ICU stay, an average of 5 days]
The time frame between start of the study and ICU discharge will be calculated.
Time to wean inotropes and vasopressors [During ICU stay, an average of 5 days]
Time to wean all inotropes and vasopressors will be calculated.
Incidence of right ventricular dysfunction [Until day 5 post-transplantation]
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)
Hypertonic saline solution (HSS) hemodynamic effect [Until day 3 post-transplantation]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Hospitalized patients submitted to orthotopic heart transplantation (HT)

Exclusion Criteria:

Requirement of renal replacement therapy before HT
Requirement of extracorporeal membrane oxygenation (ECMO) before HT
Double transplant (e.g. heart-kidney or heart-lung)
Hypernatremia (Na ≥ 145)
Moderate or severe hyponatremia (Na ≤ 120)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fernando Bacal

Investigators

Study Director: Fernando Bacal, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fernando Bacal, Director of Heart Transplant Unit (Heart Institute)., University of Sao Paulo General Hospital

ClinicalTrials.gov Identifier:

NCT05909150

Other Study ID Numbers:

HSS-HT

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Pharmaceutical Solutions

Study Results

No Results Posted as of Jun 22, 2023