Health TrialsbyHealthPanel

Hypertonic Saline Solution to Prevent Acute Kidney Injury After Heart Transplantation

ConditionsHeart TransplantationAcute Kidney Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFernando Bacal

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Hospitalized patients submitted to orthotopic heart transplantation (HT)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Hypertonic Saline Solution 3,5% (HSS)Active comparator 1 intervention
Group B: Normal Saline Solution (NS)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Prevention of acute kidney injury

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

Time frame
Days 3 -7 post-transplantation

Secondary outcomes

1

Mortality

Incidence of all cause mortality during the first 30 days after start of the study

Time frame
30 days
2

Incidence of acute kidney injury requiring hemodialysis

Rate of patients which required hemodialysis during the first 30 days after start of the study

Time frame
30 days
3

Intensive care unit (ICU) length of stay

The time frame between start of the study and ICU discharge will be calculated.

Time frame
During ICU stay, an average of 5 days
4

Time to wean inotropes and vasopressors

Time to wean all inotropes and vasopressors will be calculated.

Time frame
During ICU stay, an average of 5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fernando Bacal

Lead sponsor

University of Sao Paulo General Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now