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

Primary Purpose

Heart Transplantation, Acute Kidney Injury

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sodium chloride solution 3,5%
Sodium chloride solution 0,9%
Sponsored by
Fernando Bacal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Hypertonic Saline Solution 3,5% (HSS)

    Normal Saline Solution (NS)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Prevention of acute kidney injury
    Demonstrate a peak value of creatinine 30% lower in the active arm

    Secondary Outcome Measures

    Mortality
    Incidence of all cause mortality during the first 30 days after start of the study
    Incidence of acute kidney injury requiring hemodialysis
    Rate of patients which required hemodialysis during the first 30 days after start of the study
    Intensive care unit (ICU) length of stay
    The time frame between start of the study and ICU discharge will be calculated.
    Time to wean inotropes and vasopressors
    Time to wean all inotropes and vasopressors will be calculated.
    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)
    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)

    Full Information

    First Posted
    March 24, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Fernando Bacal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05909150
    Brief Title
    Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
    Acronym
    HSS-HT
    Official Title
    Use of Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    July 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fernando Bacal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Transplantation, Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hypertonic Saline Solution 3,5% (HSS)
    Arm Type
    Active Comparator
    Arm Title
    Normal Saline Solution (NS)
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium chloride solution 3,5%
    Intervention Description
    Patients will receive 150 mL HSS 3,5% intravenous twice daily for 3 days after heart transplantation.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium chloride solution 0,9%
    Intervention Description
    Patients will receive 150 mL NS 0,9% intravenous twice daily for 3 days after heart transplantation.
    Primary Outcome Measure Information:
    Title
    Prevention of acute kidney injury
    Description
    Demonstrate a peak value of creatinine 30% lower in the active arm
    Time Frame
    Days 3 -7 post-transplantation
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    Incidence of all cause mortality during the first 30 days after start of the study
    Time Frame
    30 days
    Title
    Incidence of acute kidney injury requiring hemodialysis
    Description
    Rate of patients which required hemodialysis during the first 30 days after start of the study
    Time Frame
    30 days
    Title
    Intensive care unit (ICU) length of stay
    Description
    The time frame between start of the study and ICU discharge will be calculated.
    Time Frame
    During ICU stay, an average of 5 days
    Title
    Time to wean inotropes and vasopressors
    Description
    Time to wean all inotropes and vasopressors will be calculated.
    Time Frame
    During ICU stay, an average of 5 days
    Title
    Incidence of right ventricular dysfunction
    Description
    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)
    Time Frame
    Until day 5 post-transplantation
    Title
    Hypertonic saline solution (HSS) hemodynamic effect
    Description
    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)
    Time Frame
    Until day 3 post-transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ciro M Murad, MD
    Phone
    +55 31988988843
    Email
    ciromurad@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Núcleo Transplante Heart Institute / University of Sao Paulo
    Phone
    +55 1126615720
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Bacal, PhD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

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