Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

Acute Kidney Injury Clinical Trial

— HSS-HT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909150
• Other study ID #: HSS-HT
• Status: Recruiting
• Phase: Phase 2
• Start date: November 8, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of Sao Paulo General Hospital
• Contact: Ciro M Murad, MD
• Phone: +55 31988988843
• Email: ciromurad[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Transplantation
• Wounds and Injuries

Intervention

Drug:
• Sodium chloride solution 3,5%
Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
• Sodium chloride solution 0,9%
Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.

Locations

Country	Name	City	State
Brazil	Heart Institute, University of São Paulo.	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Fernando Bacal

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of acute kidney injury	Demonstrate a peak value of creatinine 30% lower in the active arm	Days 3 -7 post-transplantation
Secondary	Mortality	Incidence of all cause mortality during the first 30 days after start of the study	30 days
Secondary	Incidence of acute kidney injury requiring hemodialysis	Rate of patients which required hemodialysis during the first 30 days after start of the study	30 days
Secondary	Intensive care unit (ICU) length of stay	The time frame between start of the study and ICU discharge will be calculated.	During ICU stay, an average of 5 days
Secondary	Time to wean inotropes and vasopressors	Time to wean all inotropes and vasopressors will be calculated.	During ICU stay, an average of 5 days
Secondary	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)	Until day 5 post-transplantation
Secondary	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)	Until day 3 post-transplantation